Azur Peripheral Coil System Helical HydroCoil Embolization System (Detachable) Instructions for Use

Transcription

1 Azur Peripheral Coil System Helical HydroCoil Embolization System (Detachable) Instructions for Use DEVICE DESCRIPTION The Detachable Azur Peripheral Coil System (Azur system) consists of a coil implant attached to a delivery system. The coils are platinum coils with an outer layer of hydrophilic polymer. The delivery pusher is powered by an Azur Detachment Controller to selectively detach the coils. The Azur Detachment Controller is provided separately. REQUIRED ADDITIONAL ITEMS Azur Detachment Controller Wire-reinforced microcatheter with distal tip RO marker, appropriately sized Guide catheter compatible with microcatheter Steerable guidewires compatible with microcatheter 2 rotating hemostatic Y valves (RHV) 1 three-way stopcock Sterile saline and/or lactated Ringer s injection Pressurized sterile saline drip Steam source for optional pre-softening of implant 1 one-way stopcock Stopwatch or timer WARNINGS AND PRECAUTIONS Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. The Azur system is available in a broad range of coil diameters and lengths. The coil must be delivered only through a wirereinforced microcatheter with the minimum inner diameter specified. INDICATIONS FOR USE Table 1 The Azur system is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature. This device should only be used by physicians who have undergone training in the use of the Azur system for embolization procedures as prescribed by a representative from Terumo or a Terumo-authorized distributor. CONTRAINDICATIONS Use of the Azur system is contraindicated in any of the following circumstances: Coil Type When superselective coil placement is not possible. When end arteries lead directly to nerves. When arteries supplying the lesion to be treated are not large enough to accept emboli. When the A-V shunt is larger than the coil. In the presence of severe atheromatous disease. In the presence of vasospasm (or likely onset of vasospasm). POTENTIAL COMPLICATIONS Minimum Microcatheter I.D. inches mm Reposition Time Azur Detachable minutes Azur Detachable minutes Potential complications include, but are not limited to: hematoma at the site of entry, vessel/aneurysm perforation, unintended parent artery occlusion, incomplete filling, vascular thrombosis, hemorrhage, ischemia, vasospasm, edema, coil migration or misplacement, premature or difficult coil detachment, clot formation, revascularization, post-embolization syndrome, and neurological deficits including stroke and possibly death. The physician should be aware of these complications and instruct patients when indicated. Appropriate patient management should be considered. The Azur system is supplied sterile and non-pyrogenic unless package is opened or damaged. This device is intended for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. Angiography is required for pre-embolization evaluation, operative control, and post-embolization follow up. Do not advance the delivery pusher with excessive force. Determine the cause of any unusual resistance, remove the Azur system, and check for damage. Advance and retract the Azur system slowly and smoothly. Remove the entire Azur system if excessive friction is noted. If excessive friction is noted with a second Azur system, check the microcatheter for damage or kinking. The coil must be properly positioned in the vessel or aneurysm within three minutes from the time the device is first introduced into the microcatheter. If the coil cannot be positioned and detached within this time, simultaneously remove the device and the microcatheter. Positioning the device in a low-flow environment may increase the reposition time. If repositioning is necessary, take special care to retract the coil under fluoroscopy in a one-to-one motion with the delivery pusher. If the coil does not move in a one-to-one motion with the delivery pusher, or if repositioning is difficult, the coil may have become stretched and could possibly break. Gently remove and discard the entire device. Due to the delicate nature of the coils, the tortuous vascular pathways that lead to certain lesions, and the varying morphologies of the vasculature, a coil may occasionally stretch while being maneuvered. Stretching is a precursor to potential coil breakage and migration. If a coil must be retrieved from the vasculature after detachment, do not attempt to withdraw the coil with a retrieval device, such as a snare, into the delivery catheter. This could damage the coil and result in device separation. Remove the coil, microcatheter, and any retrieval device from the vasculature simultaneously. Delivery of multiple coils is usually required to achieve the desired occlusion of some vasculatures or lesions. The desired procedural endpoint is usually angiographic occlusion. The filling properties of the coils facilitate angiographic occlusion and reduce the need to tightly pack with numerous coils. Tortuosity or complex vessel anatomy may affect accurate placement of the coil. The long-term effect of this product on extravascular tissues has not been established so care should be taken to retain this device in the intravascular space. Always ensure that at least two Azur Detachment Controllers are available before starting an Azur system procedure.

2 The coil cannot be detached with any power source other than an Azur Detachment Controller. Do NOT place the delivery pusher on a bare metallic surface. Always handle the delivery pusher with surgical gloves. Do NOT use in conjunction with radio frequency (RF) devices. Figure 1 Diagram of Azur System Setup PREPARATION FOR USE 1. Refer to Figure 1 for the set-up diagram. 2. Attach a rotating hemostatic valve (RHV) to the hub of the guiding catheter. Attach a 3-way stopcock to the side arm of the RHV and then connect a line for continuous infusion of flush solution. 3. Attach a second RHV to the hub of the microcatheter. Attach a 1- way stopcock to the sidearm of the second RHV and connect the flush solution line to the stopcock. 4. Open the stopcock and flush the microcatheter with sterile flush solution and then close the stopcock. To minimize the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate sterile flush solution be maintained into the guide catheter, the femoral sheath and the microcatheter. CATHETERIZATION OF THE LESION 5. Using standard interventional procedures, access the vessel with a guide catheter. The guide catheter should have an inner diameter (ID) large enough to allow for contrast injection while the microcatheter is in place. This will allow for fluoroscopic road mapping during the procedure. 6. Select a microcatheter with the appropriate inner diameter. After the microcatheter has been positioned inside the lesion, remove the guidewire. 10. For aneurysm occlusion, the diameter of the first and second coils should never be less than the width of the aneurysm neck or the propensity for the coils to migrate may be increased. The diameter of the first helical coil should be 1-2 mm smaller than the initial basket coil or aneurysm dome. 11. For vessel occlusion, select a coil size that is slightly larger than the vessel diameter. 12. Correct coil selection increases effectiveness and patient safety. Occlusive efficiency is, in part, a function of compaction and overall coil mass. In order to choose the optimum coil for any given lesion, examine the pre-treatment angiograms. The appropriate coil size should be chosen based upon angiographic assessment of the diameter of the target or parent vessel, aneurysm dome and aneurysm neck. NOTE: The coils include an outer layer of a hydrophilic polymer. The primary coil diameter and the secondary coil diameter (dimension A on the package label) will increase by approximately 0.5 mm following hydration. PREPARATION OF THE AZUR SYSTEM FOR DELIVERY COIL SIZE SELECTION 7. Perform fluoroscopic road mapping. 8. Measure and estimate the size of the lesion to be treated. 9. At the discretion of the physician, one or more framing coils (platinum 3D coils) may be used to establish an initial framework

3 injection or flow of steam, gently retract the implant back completely into the introducer sheath about 1 to 2 cm. INTRODUCTION AND DEPLOYMENT OF THE AZUR SYSTEM Figure 2 Azur Detachment Controller 13. Remove the Azur Detachment Controller from its protective packaging. Pull the white pull-tab from the side of the detachment controller. Discard the pull-tab and place the detachment controller in the sterile field. The Azur Detachment Controller is packaged separately as a sterile device. Do not use any power source other than the Azur Detachment Controller to detach the coil. The Azur Detachment Controller is intended to be used on one patient. Do not attempt to re-sterilize or otherwise re-use the Azur Detachment Controller. 14. Prior to using the device, remove the proximal end of the delivery pusher from the packaging hoop. Use care to avoid contaminating this end of the delivery pusher with foreign substances such as blood or contrast. Firmly insert the proximal end of the delivery pusher into the funnel section of the Azur Detachment Controller. See Figure 2. Do not push the detachment button at this time. 15. Wait three seconds and observe the indicator light on the detachment controller. If the green light does not appear or if a red light appears, replace the device. If the light turns green, then turns off at any time during the three-second observation, replace the device. If the green light remains solid green for the entire threesecond observation, continue using the device. 16. Hold the device just distal to the shrink-lock and pull the shrinklock proximally to expose the tab on introducer sheath. See Figure 3. Tab on introducer sheath Pull shrink-lock proximally Figure 3 - Pull Shrink Lock Proximally 17. Slowly advance the coil out of the introducer sheath and inspect the coil for any irregularities or damage. If any damage to the coil or delivery pusher is observed, DO NOT use the device. 18. If pre softening of the Azur implant is desired, advance it out of the distal end of the introducer sheath and immerse it in warm sterile saline or warm lactated Ringer s injection. Alternatively, hold it in a flow of steam until it curls, usually about five to ten seconds. When using steam, appropriate sterile technique should be used. In addition, the Azur system may be used without presoftening. 19. With the distal end of the introducer sheath pointed downward and the implant still in the warm saline, warm lactated Ringer s 20. Open the RHV on the microcatheter just enough to accept the introducer sheath of the Azur system. 21. Insert the introducer sheath of the Azur system through the RHV. Flush the introducer until it is completely purged of air and saline flush exits the proximal end. 22. Seat the distal tip of the introducer sheath at the distal end of the microcatheter hub and close the RHV lightly around the introducer sheath to secure the RHV to the introducer. Do not over-tighten the RHV around the introducer sheath. Excessive tightening could damage the device. 23. Push the coil into the lumen of the microcatheter. Use caution to avoid catching the coil on the junction between the introducer sheath and the hub of the microcatheter. Initiate timing using a stopwatch or timer at the moment the device enters the microcatheter. Detachment must occur within the specified reposition time. 24. Push the Azur system through the microcatheter until the proximal end of the delivery pusher meets the proximal end of the introducer sheath. Loosen the RHV. Retract the introducer sheath just out of the RHV. Close the RHV around the delivery pusher. Slide the introducer sheath completely off of the delivery pusher. Use care not to kink the delivery system. To prevent premature hydration of the Azur system, ensure that there is flow from the saline flush. 25. Discard the introducer sheath. The Azur system cannot be resheathed after introduction into the microcatheter. 26. At this time, fluoroscopic guidance should be initiated. Depending on length of microcatheter used, fluoroscopy initiation may be delayed to minimize exposure. 27. Under fluoroscopic guidance, slowly advance the coil out the tip of the microcatheter. Continue to advance the coil into the lesion until optimal deployment is achieved. Reposition if necessary. If the coil size is not suitable, remove and replace with another device. If undesirable movement of the coil is observed under fluoroscopy following placement and prior to detachment, remove the coil and replace with another more appropriately sized coil. Movement of the coil may indicate that the coil could migrate once it is detached. DO NOT rotate the delivery pusher during or after delivery of the coil into the vasculature. Rotating the delivery pusher may result in a stretched coil or premature detachment of the coil from the delivery pusher, which could result in coil migration. Angiographic assessment should also be performed prior to detachment to ensure that the coil mass is not protruding into undesired vasculature. 28. Complete the deployment and any repositioning so that the coil will be detached within the reposition time specified in Table 1. After the specified time, the swelling of the hydrophilic polymer may prevent passage through the microcatheter and damage the coil. If the coil cannot be properly positioned and detached within the specified time, simultaneously remove the device and the microcatheter. 29. Advance the coil into the desired site until the radiopaque marker on the delivery pusher is aligned or slightly distal of microcatheter distal tip RO marker, positioning the detachment zone just outside the microcatheter tip. See Figure Tighten the RHV to prevent movement of the coil. 31. Verify repeatedly that the distal shaft of the delivery pusher is not under stress before coil detachment. Axial compression or tension could cause the tip of the microcatheter to move during coil delivery. Catheter tip movement could cause the aneurysm or vessel to perforate

4 the microcatheter lumen to ensure that no part of the last coil remains within the microcatheter. The physician has the discretion to modify the coil deployment technique to accommodate the complexity and variation in embolization procedures. Any technique modifications must be consistent with the previously described procedures, warnings, precautions and patient safety information. SPECIFICATIONS FOR AZUR DETACHMENT CONTROLLER Figure 4 Position of Marker Bands for Detachment To minimize the potential risk of aneurysm or vessel perforation DO NOT advance the distal end of the delivery system past the distal tip of the microcatheter. DETACHMENT OF THE COIL 32. The Azur Detachment Controller is pre-loaded with battery power and will activate when a delivery pusher is properly connected. It is in a power off mode when no delivery pusher is attached. It is not necessary to push the button on the side of the Azur Detachment Controller to activate it. 33. Verify that the RHV is firmly locked around the delivery pusher before attaching the Azur Detachment Controller to ensure that the coil does not move during the connection process. 34. Although the delivery pusher s gold connectors are designed to be compatible with blood and contrast, every effort should be made to keep the connectors free of these items. If there appears to be blood or contrast on the connectors, wipe the connectors with sterile water or saline solution before connecting to the Azur Detachment Controller. 35. Connect the proximal end of the delivery pusher to the Azur Detachment Controller by firmly inserting the proximal end of the delivery pusher into the funnel section of the Azur Detachment Controller. See Figure When the Azur Detachment Controller is properly connected to the delivery pusher, a single audible tone will sound and the light will turn green to signal that it is ready to detach the coil. If the detachment button is not pushed within 30 seconds, the solid green light will slowly flash green. Both flashing green and solid green lights indicate that the device is ready to detach. If the green light does not appear, check to ensure that the connection has been made. If the connection is correct and no green light appears, replace the Azur Detachment Controller. 37. Verify the coil position before pushing the detachment button. 38. Push the detachment button. When the button is pushed, an audible tone will sound and the light will flash green. 39. At the end of the detachment cycle, three audible tones will sound and the light will flash yellow three times. This indicates that the detachment cycle is complete. If the coil does not detach during the detachment cycle, leave the Azur Detachment Controller attached to the delivery pusher and attempt another detachment cycle when the light turns green. 40. The light will turn red after the number of detachment cycles specified on the Azur Detachment Controller labeling. DO NOT use the Azur Detachment Controller if the light is red. Discard the Azur Detachment Controller and replace it with a new one when the light is red. 41. Verify detachment of the coil by first loosening the RHV valve, then pulling back slowly on the delivery system and verifying that there is no coil movement. If the implant did not detach, do not attempt to detach it more than two additional times. If it does not detach after the third attempt, remove the delivery system. 42. After detachment has been confirmed, slowly retract and remove the delivery pusher. Advancing the delivery pusher once the coil has been detached involves the risk of aneurysm or vessel rupture. Do NOT advance the delivery pusher once the coil has been detached. 43. Verify the position of the coil angiographically through the guide catheter. 44. Additional coils may be deployed into the lesion as described above. Prior to removing the microcatheter from the treatment site, place an appropriately sized guidewire completely through Output voltage: 8 ± 1 VDC Cleaning, preventative inspection, and maintenance: The Azur Detachment Controller is a single use device, preloaded with battery power, and packaged sterile. No cleaning, inspection, or maintenance is required. If the device does not perform as described in the Detachment section of these Instructions, discard the Azur Detachment Controller and replace it with a new unit. The Azur Detachment Controller is a single use device. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. Batteries are pre-loaded into the Azur Detachment Controllers. Do not attempt to remove or replace the batteries prior to use. After use, dispose of the Azur Detachment Controller in a manner consistent with local regulations. PACKAGING AND STORAGE The Azur system is placed inside a protective, plastic dispenser hoop and packaged in a pouch and unit carton. The Azur system and dispenser hoop will remain sterile unless the package is opened, damaged, or the expiration date has passed. Store at a controlled room temperature in a dry place. The Azur Detachment Controller is packaged separately in a protective pouch and carton. The Azur Detachment Controller has been sterilized; it will remain sterile unless the pouch is opened, damaged, or the expiration date has passed. Store at a controlled room temperature in a dry place. SHELF LIFE See the product label for the device shelf life. Do not use the device beyond the labeled shelf life. MR INFORMATION The coil implant has been determined to be MR conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F Non-clinical testing demonstrated that the coil implant is MR conditional. A patient can be scanned safely, immediately after placement under the following conditions: Static magnetic field of 3 Tesla or less Maximum spatial gradient field of 720 Gauss/cm or less MRI-Related Heating In non-clinical testing, the coil implant produced a maximum temperature rise of 1.7 C during MRI performed for 15 minutes of - 4 -

5 scanning in the 3 Tesla (3-Tesla/128-MHz, Excite, HDx, Software 14X.M5, General Electric Healthcare, Milwaukee, WI) MR system. Therefore, the MRI-related heating experiments for the coil implant at 3 Tesla using a transmit/receive RF body coil at an MR system reported whole body averaged SAR of 2.9 W/kg (i.e., associated with a calorimetry measured whole body averaged value of 2.7 W/kg) indicated that the greatest amount of heating that occurred in association with these specific conditions was equal to or less than 1.7 C. MR Conditional Non-pyrogenic Upper limit of temperature Image Artifact Information MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the coil implant. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary. Pulse Sequence: T1-SE T1-SE GRE GRE Plane Orientation: Parallel Perpendicular Parallel Perpendicular Signal Void Size: 511 mm 2 80 mm mm mm 2 Terumo Corporation recommends that the patient register the MR conditions disclosed in this IFU with the MedicAlert Foundation or equivalent organization. MATERIALS The Azur system does not contain latex or PVC materials. SYMBOLS Lot Number Order Number WARRANTY Terumo warrants that reasonable care has been used in the design and manufacture of this device. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for particular purpose. Handling, storage, cleaning, and sterilization of the device as well as factors relating to the patient, diagnosis, treatment, surgical procedure, and other matters beyond Terumo s control directly affect the device and the results obtained from its use. Terumo s obligation under this warranty is limited to the repair or replacement of this device through its expiration date. Terumo shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly arising from the use of this device. Terumo neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this device. Terumo assumes no liability with respect to devices reused, reprocessed or resterilized and makes no warranties, expressed or implied, including, but not limited to, merchantability or fitness for intended use, with respect to such device. Prices, specifications, and model availability are subject to change without notice. Copyright 2012 Terumo Corporation. All rights reserved. Terumo and Azur are registered trademarks of Terumo Corporation. MicroVention and HydroCoil are registered trademarks of MicroVention, Inc. Content Sterilized Using Irradiation Sterilized Using Ethylene Oxide Manufacturer: MicroVention, Inc Valencia Avenue Tustin, CA USA Tel: Do Not Reuse Use-by Date Distributed by: Terumo Medical Corporation 2101 Cottontail Lane Somerset, NJ Tel: (800) Date of Manufacture Attention, Consult Accompanying Documents Type BF Applied Part Authorized European Representative: MicroVention Europe 30 bis, rue du Vieil Abreuvoir Saint-Germain-en-Laye France Tel: +33 (0) Fax: +33 (0) Power ON and OFF 0297 PD Rev. B Revised CE Mark Manufacturer Authorized European Representative - 5 -

6 Sterile saline Pressurized sterile saline drip One-way stopcock 1cc syringe Azur Peripheral Coil System Helical HydroCoil Embolization System (Pushable) Instructions for Use DEVICE DESCRIPTION The Pushable Azur Peripheral Coil System (Azur system) consists of a coil implant packaged in a coil introducer along with an introducer stylet. The coil is platinum-based with an outer layer of hydrogel polymer. The Azur system is available in helical 18-system and helical 35-system configurations. Both configurations are available in a broad range of secondary diameters and lengths to meet the needs of the physician. Each system must be delivered through a microcatheter or catheter within the specified ID range, using a specified guidewire size. System Catheter/Microcatheter ID inches mm 18-system system System inches Guidewire OD mm 18-system system INDICATIONS FOR USE The Azur system is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature. This device should only be used by physicians who have undergone training in the use of the Azur system for embolization procedures as prescribed by a representative from Terumo or a Terumo-authorized distributor. CONTRAINDICATIONS Use of the Azur system is contraindicated in any of the following circumstances: When superselective coil placement is not possible. When end arteries lead directly to nerves. When arteries supplying the lesion to be treated are not large enough to accept emboli. When the A-V shunt is larger than the coil. In the presence of severe atheromatous disease. In the presence of vasospasm (or likely onset of vasospasm). POTENTIAL COMPLICATIONS Potential complications include, but are not limited to: hematoma at the site of entry, vessel/aneurysm perforation, unintentional occlusion of the parent artery, incomplete filling, emboli, hemorrhage, ischemia, vasospasm, edema, coil migration or misplacement, clot formation, revascularization, post-embolization syndrome, and neurological deficits including stroke and possibly death. REQUIRED ADDITIONAL ITEMS Appropriately-sized catheter/microcatheter (with wire reinforcement required for delivery through tortuous vasculature) Steerable guidewire compatible with coil system and delivery catheter/microcatheter Rotating hemostatic Y valve (RHV) WARNINGS AND PRECAUTIONS Federal law (USA) restricts this device to sale by or on the order of a physician. The Azur system is sterile and non-pyrogenic unless the unit package is opened or damaged. The Azur system is intended for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. Angiography is required for pre-embolization evaluation, operative control, and post-embolization follow up. Fluoroscopic roadmapping is recommended to achieve optimal device placement. Always inspect the Azur system prior to both preparation and insertion to ensure that the coil has not shifted within the introducer or migrated into the introducer caps. If the coil is not secure within the introducer prior to both the preparation and introduction processes, damage may result. Hydration of the Azur system prior to use is mandatory. A 3- minute hydration period is required to soften the coil. Failure to hydrate may result in the coil not taking its secondary shape, which can result in deployment away from the intended location, migration, or protrusion outside the delivery location. The coil must be delivered through a compatibly-sized catheter or microcatheter with a PTFE inner surface coating using a compatibly-sized guidewire. Failure to correctly size the delivery system may result in damage to the device and necessitate removal of both the device and delivery catheter from the patient. Always select a wire-reinforced delivery catheter/microcatheter when delivering the coil through highly tortuous vasculature. Nonreinforced catheters may ovalize under such circumstances, potentially resulting in coil damage and necessitating removal of both the device and delivery catheter from the patient. Do not use a syringe to deliver the coil. The coil is intended to be delivered using a compatible guidewire only. Delivery via syringe injection may result in the coil not taking its secondary shape, which can result in deployment away from the intended location, migration, or protrusion outside the delivery location. Do not advance the coil with excessive force. If unusual resistance is noted during advancement, determine its cause before proceeding by verifying the appropriate delivery catheter and guidewire are being used, and that both are free from damage and kinking. If necessary, replace the delivery catheter, coil, and/or guidewire before proceeding. The coil is not retractable or repositionable. If a coil must be retrieved from the vasculature after deployment, do not attempt to withdraw the coil with a retrieval device, such as a snare, into the delivery catheter. This could damage the coil and result in device separation. Remove the coil, microcatheter, and any retrieval device from the vasculature simultaneously. If the coil and/or pushing guidewire get stuck within the delivery catheter lumen, do not continue advancing. Remove the catheter, and replace the catheter, coil, and/or guidewire when necessary. Delivery of multiple coils is generally required to achieve the desired occlusion of some vessels, aneurysms, and vascular lesions. The desired procedural endpoint is angiographic occlusion. The filling properties of the coil facilitate angiographic occlusion and reduce the need to tightly pack. Multiple embolization procedures may be required to achieve the desired occlusion of some vessels/vascular lesions.

7 Tortuosity or complex vessel anatomy may affect accurate placement of the coil. The long-term effect of this product on extravascular tissues has not been established. Care should be taken to retain the device in the intravascular space. Always advance an appropriately-sized guidewire through the delivery catheter after deployment to ensure that no part of the coil remains within the catheter prior to delivering the next coil or removing the catheter from the patient. Diagram of Azur System Setup PREPARATION FOR USE 1. Refer to the setup diagram. 2. Select the catheter or microcatheter to be used for coil delivery. Select a compatible pushing guidewire. 3. Attach an RHV to the hub of the delivery catheter/microcatheter. Attach a one-way stopcock to the side arm of the RHV and connect the flush solution line to the stopcock. (If fluoroscopic roadmapping is being used, an appropriate guide catheter with attached RHV and flush solution line must be incorporated as well.) 4. Open the stopcock and flush the delivery catheter with sterile flush solution. Close the stopcock. To minimize the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate sterile flush solution be maintained into the delivery catheter (and femoral sheath, if present). CATHETERIZATION OF THE LESION 5. Access the parent vessel or vascular structure using standard interventional procedures. 6. Position the delivery catheter for pushable coil deployment as close to the target lesions as possible, using standard technique. Remove the guidewire, if used. COIL SIZE SELECTION 7. Measure or estimate the size of the vessel or lesion to be treated. 8. Select appropriately sized coils. The diameter of the first and second coils placed should never be less than the diameter of the vessel to be treated or less than the neck width of the aneurysm to be treated, or the propensity for the coils to migrate may be increased. For vessel occlusion, it is suggested that the diameter of the initial coil placed be slightly larger than the actual vessel diameter to prevent displacement or migration. For aneurysm treatment, coils placed within the aneurysm sac must not be larger than the dome size, or protrusion of the coil from the sac may result. 9. Correct coil selection increases effectiveness and patient safety. Occlusive efficiency is, in part, a function of compaction and overall coil mass. In order to choose the optimum coil for any given lesion, examine the pre-treatment angiograms. The appropriate coil size should be chosen based upon angiographic assessment of the treatment site. For vessel occlusion, the diameter of the vessel must be considered. In the case of aneurysms, diameter of the parent vessel, aneurysm dome size, and aneurysm neck width must be considered. NOTE: The coil has an outer layer consisting of a hydrophilic polymer. As a result, the secondary coil diameter (dimension A on the package label) will increase by approximately 0.5 mm following full hydration (approx. 20 minutes). PREPARATION FOR DELIVERY 10. Remove both the coil (in its introducer) and stylet from the protective pouch. 11. Verify the cap is present and secure on the distal end of the introducer and that the introducer is free from damage. If any damage is observed, DO NOT use the system. 12. Verify the coil is properly positioned in the introducer. If the coil has migrated proximally into the introducer hub, gently tap the distal end of the introducer onto a flat surface until the proximal end is no longer visible in the hub. If it has migrated distally into the cap, gently tap the proximal end of the introducer onto a flat surface until the distal end returns to the tube. 13. Remove the proximal cap from the introducer hub. 14. Fill a 1-cc syringe with saline. Connect the syringe to the introducer hub. Hold the introducer in a level position and slowly and gently inject saline until saline emerges from the vented distal cap. Allow the coil to remain in the introducer for 3 minutes, leaving the syringe attached. This helps - 2 -

8 ensure coil hydration and softening, which allows the coil to quickly take its secondary shape upon delivery. Verify that the coil has not migrated into the hub or distal cap prior to proceeding. NOTE: Do not overpressurize the introducer during hydration by holding the introducer upright or injecting too quickly. Doing so may result in migration of the coil into the distal cap or premature removal of the cap, which may result in coil damage. INTRODUCTION AND DEPLOYMENT OF THE AZUR SYSTEM NOTE: Do not proceed with coil introduction and deployment until after completion of the 3-minute saline hydration period. 15. Open the RHV on the delivery catheter just enough to accept the introducer. 16. Verify that the syringe is still attached to the introducer. Remove the distal cap and insert the introducer through the RHV. Seat the distal tip of the introducer in the ID of the delivery catheter hub and lightly close the RHV around the introducer to secure it in place. The introducer must be seated in the hub prior to tightening the RHV. If the introducer is not seated, the coil may get caught in the resulting gap, potentially causing damage and inability to complete insertion. 17. Remove the syringe from the introducer hub and immediately insert the stylet. Using the stylet, push the coil through the introducer, RHV, and catheter hub, into the lumen of the delivery catheter. Advance the stylet completely, until its shaped end seats on the introducer hub. This will ensure that the coil has been fully inserted into the catheter lumen. If the coil does not advance easily into the catheter lumen, rotate the introducer ½ turn while keeping it seated within the catheter hub, and advance the coil with the stylet. Use caution to avoid catching the coil on the junction between the introducer and the delivery catheter hub. Once the coil has been introduced into the delivery catheter lumen, no more than 3 minutes must pass prior to coil delivery. 18. Remove and discard the coil introducer and stylet. To prevent premature expansion of the coil, ensure that there is continuous intralumenal flow from the saline flush. 19. Insert an appropriately-sized pushing guidewire through the RHV. Using the guidewire, slowly advance the coil through the delivery catheter until it exits the catheter tip. Continue to slowly advance the coil into the lesion or vessel, adjusting catheter positioning as necessary, until optimal deployment is achieved. Complete the deployment within 3 minutes. After 3 minutes, swelling of the hydrophilic polymer may prevent passage through the delivery catheter and result in damage to the coil. NOTE: It is recommended to secure the catheter in place during coil advancement and delivery to prevent the catheter tip from moving away from the intended delivery location. 20. Once the coil has been deployed and prior to removing the delivery catheter, advance the guidewire through the catheter tip to verify that no part of the coil remains within the catheter lumen. The physician has the discretion to modify the coil deployment technique to accommodate the complexity and variation in embolization procedures. Any technique modifications must be consistent with the previously-described procedures, warnings, precautions, and patient safety information. PACKAGING AND STORAGE The coil is provided in a capped coil introducer, and, together with a stylet, is packaged inside a protective pouch. There are three pouched devices in each unit carton. The coil, the coil introducer, and the stylet all remain sterile unless the package is opened, damaged, or the expiration date has passed. Store at a controlled room temperature in a dry place. SHELF LIFE See the product label for device shelf life. Do not use the device beyond the labeled shelf life. MR INFORMATION The coil implant has been determined to be MR conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F Non-clinical testing demonstrated that the coil implant is MR conditional. A patient can be scanned safely, immediately after placement under the following conditions: Static magnetic field of 3 Tesla or less Maximum spatial gradient field of 720 Gauss/cm or less MRI-Related Heating In non-clinical testing, the coil implant produced a maximum temperature rise of 1.7 C during MRI performed for 15 minutes of scanning in the 3 Tesla (3-Tesla/128-MHz, Excite, HDx, Software 14X.M5, General Electric Healthcare, Milwaukee, WI) MR system. Therefore, the MRI-related heating experiments for the coil implant at 3 Tesla using a transmit/receive RF body coil at an MR system reported whole body averaged SAR of 2.9 W/kg (i.e., associated with a calorimetry measured whole body averaged value of 2.7 W/kg) indicated that the greatest amount of heating that occurred in association with these specific conditions was equal to or less than 1.7 C. Image Artifact Information MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the coil implant. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary. Pulse Sequence: T1-SE T1-SE GRE GRE Plane Orientation: Parallel Perpendicular Parallel Perpendicular Signal Void Size: 511 mm 2 80 mm mm mm 2 Terumo Corporation recommends that the patient register the MR conditions disclosed in this IFU with the MedicAlert Foundation or equivalent organization. MATERIALS The Azur system does not contain latex or PVC materials. SYMBOLS Lot Number Order Number Content Sterilized Using Irradiation Do Not Reuse Use-by Date - 3 -

9 Date of Manufacture Attention, Consult Accompanying Documents 0297 PD Rev. A Revised CE Mark Manufacturer Authorized European Representative MR Conditional Non-pyrogenic Upper limit of temperature WARRANTY Terumo warrants that reasonable care has been used in the design and manufacture of this device. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for particular purpose. Handling, storage, cleaning and sterilization of the device as well as factors relating to the patient, diagnosis, treatment, surgical procedure and other matters beyond Terumo s control directly affect the device and the results obtained from its use. Terumo s obligation under this warranty is limited to the repair or replacement of this device through its expiration date. Terumo shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly arising from the use of this device. Terumo neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this device. Terumo assumes no liability with respect to devices reused, reprocessed or resterilized and makes no warranties, expressed or implied, including, but not limited to, merchantability or fitness for intended use, with respect to such device. Prices, specifications and model availability are subject to change without notice. Copyright 2012 Terumo Corporation. All rights reserved. Terumo and Azur are registered trademarks of Terumo Corporation. MicroVention and HydroCoil are registered trademarks of MicroVention, Inc. Manufacturer: MicroVention, Inc Valencia Avenue Tustin, CA USA Tel: (714) Distributed by: Terumo Medical Corporation 2101 Cottontail Lane Somerset, NJ Tel: (800) Authorized European Representative: MicroVention Europe 30 bis, rue du Vieil Abreuvoir Saint-Germain-en-Laye France Tel: +33 (0) Fax: +33 (0)

10 Azur Peripheral Coil System Framing Coil (Detachable) Instructions for Use Steerable guidewires compatible with microcatheter 2 rotating hemostatic Y valves (RHV) 1 three-way stopcock Sterile saline Pressurized sterile saline drip 1 one-way stopcock WARNINGS AND PRECAUTIONS DEVICE DESCRIPTION The Detachable Azur Peripheral Coil System Framing Coil (Azur system) consists of a coil implant attached to a delivery system. The coils are platinum coils. The delivery pusher is powered by an Azur Detachment Controller to selectively detach the coils. The Azur Detachment Controller is provided separately. The Azur system is available in a broad range of coil diameters and lengths. The coil must be delivered only through a wirereinforced microcatheter with the minimum inner diameter specified. INDICATIONS FOR USE Table 1 The Azur system is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature. This device should only be used by physicians who have undergone training in the use of the Azur system for embolization procedures as prescribed by a representative from Terumo or a Terumo-authorized distributor. CONTRAINDICATIONS Use of the Azur system is contraindicated in any of the following circumstances: Coil Type When superselective coil placement is not possible. When end arteries lead directly to nerves. When arteries supplying the lesion to be treated are not large enough to accept emboli. When the A-V shunt is larger than the coil. In the presence of severe atheromatous disease. In the presence of vasospasm (or likely onset of vasospasm). POTENTIAL COMPLICATIONS Minimum Microcatheter I.D. inches mm Azur Detachable Azur Detachable Potential complications include, but are not limited to: hematoma at the site of entry, vessel/aneurysm perforation, unintended parent artery occlusion, incomplete filling, vascular thrombosis, hemorrhage, ischemia, vasospasm, edema, coil migration or misplacement, premature or difficult coil detachment, clot formation, revascularization, post-embolization syndrome, and neurological deficits including stroke and possibly death. The physician should be aware of these complications and instruct patients when indicated. Appropriate patient management should be considered. REQUIRED ADDITIONAL ITEMS Azur Detachment Controller Wire-reinforced microcatheter with distal tip RO marker, appropriately sized Guide catheter compatible with microcatheter Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. The Azur system is supplied sterile and non-pyrogenic unless package is opened or damaged. This device is intended for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. Angiography is required for pre-embolization evaluation, operative control, and post-embolization follow up. Do not advance the delivery pusher with excessive force. Determine the cause of any unusual resistance, remove the Azur system, and check for damage. Advance and retract the Azur system slowly and smoothly. Remove the entire Azur system if excessive friction is noted. If excessive friction is noted with a second Azur system, check the microcatheter for damage or kinking. Due to the delicate nature of the coils, the tortuous vascular pathways that lead to certain lesions, and the varying morphologies of the vasculature, a coil may occasionally stretch while being maneuvered. Stretching is a precursor to potential coil breakage and migration. If repositioning is necessary, take special care to retract the coil under fluoroscopy in a one-to-one motion with the delivery pusher. If the coil does not move in a one-to-one motion with the delivery pusher, or if repositioning is difficult, the coil may have become stretched and could possibly break. Gently remove and discard the entire device. If a coil must be retrieved from the vasculature after detachment, do not attempt to withdraw the coil with a retrieval device, such as a snare, into the delivery catheter. This could damage the coil and result in device separation. Remove the coil, microcatheter, and any retrieval device from the vasculature simultaneously. Delivery of multiple coils is usually required to achieve the desired occlusion of some vasculatures or lesions. The desired procedural endpoint is usually angiographic occlusion. The filling properties of the coils facilitate angiographic occlusion and reduce the need to tightly pack with numerous coils. Tortuosity or complex vessel anatomy may affect accurate placement of the coil. Always advance an appropriately sized guidewire through the microcatheter after detaching the coil and removing the pusher to ensure that no part of the coil remains within the microcatheter. The long-term effect of this product on extravascular tissues has not been established so care should be taken to retain this device in the intravascular space. Always ensure that at least two Azur Detachment Controllers are available before starting an Azur system procedure. The coil cannot be detached with any power source other than an Azur Detachment Controller. Do NOT place the delivery pusher on a bare metallic surface. Always handle the delivery pusher with surgical gloves. Do NOT use in conjunction with radio frequency (RF) devices.

11 Figure 1 Diagram of Azur System Setup PREPARATION FOR USE 1. Refer to Figure 1 for the set-up diagram. 2. Attach a rotating hemostatic valve (RHV) to the hub of the guiding catheter. Attach a 3-way stopcock to the side arm of the RHV and then connect a line for continuous infusion of flush solution. 3. Attach a second RHV to the hub of the microcatheter. Attach a 1- way stopcock to the sidearm of the second RHV and connect the flush solution line to the stopcock. 4. Open the stopcock and flush the microcatheter with sterile flush solution and then close the stopcock. To minimize the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate sterile flush solution be maintained into the guide catheter, the femoral sheath and the microcatheter. 11. For vessel occlusion, select a coil size that is slightly larger than the vessel diameter. 12. Correct coil selection increases effectiveness and patient safety. Occlusive efficiency is, in part, a function of compaction and overall coil mass. In order to choose the optimum coil for any given lesion, examine the pre-treatment angiograms. The appropriate coil size should be chosen based upon angiographic assessment of the diameter of the target or parent vessel, aneurysm dome and aneurysm neck. PREPARATION OF THE AZUR SYSTEM FOR DELIVERY CATHETERIZATION OF THE LESION 5. Using standard interventional procedures, access the vessel with a guide catheter. The guide catheter should have an inner diameter (ID) large enough to allow for contrast injection while the microcatheter is in place. This will allow for fluoroscopic road mapping during the procedure. 6. Select a microcatheter with the appropriate inner diameter. After the microcatheter has been positioned inside the lesion, remove the guidewire. COIL SIZE SELECTION 7. Perform fluoroscopic road mapping. 8. Measure and estimate the size of the lesion to be treated. 9. At the discretion of the physician, one or more Azur Framing Coils (platinum 3D coils) may be used to establish an initial framework. 10. For aneurysm occlusion, the diameter of the first and second coils should never be less than the width of the aneurysm neck or the propensity for the coils to migrate may be increased. Figure 2 Azur Detachment Controller 13. Remove the Azur Detachment Controller from its protective packaging. Pull the white pull-tab from the side of the detachment controller. Discard the pull-tab and place the detachment - 2 -

12 controller in the sterile field. The Azur Detachment Controller is packaged separately as a sterile device. Do not use any power source other than the Azur Detachment Controller to detach the coil. The Azur Detachment Controller is intended to be used on one patient. Do not attempt to re-sterilize or otherwise re-use the Azur Detachment Controller. 14. Prior to using the device, remove the proximal end of the delivery pusher from the packaging hoop. Use care to avoid contaminating this end of the delivery pusher with foreign substances such as blood or contrast. Firmly insert the proximal end of the delivery pusher into the funnel section of the Azur Detachment Controller. See Figure 2. Do not push the detachment button at this time. 15. Wait three seconds and observe the indicator light on the detachment controller. If the green light does not appear or if a red light appears, replace the device. If the light turns green, then turns off at any time during the three-second observation, replace the device. If the green light remains solid green for the entire threesecond observation, continue using the device. 16. Hold the device just distal to the shrink-lock and pull the shrinklock proximally to expose the tab on introducer sheath. See Figure 3. the coil size is not suitable, remove and replace with another device. If undesirable movement of the coil is observed under fluoroscopy following placement and prior to detachment, remove the coil and replace with another more appropriately sized coil. Movement of the coil may indicate that the coil could migrate once it is detached. DO NOT rotate the delivery pusher during or after delivery of the coil into the vasculature. Rotating the delivery pusher may result in a stretched coil or premature detachment of the coil from the delivery pusher, which could result in coil migration. Angiographic assessment should also be performed prior to detachment to ensure that the coil mass is not protruding into undesired vasculature. 25. Advance the coil into the desired site until the radiopaque marker on the delivery pusher is aligned or slightly distal of microcatheter distal tip RO marker, positioning the detachment zone just outside the microcatheter tip. See Figure Tighten the RHV to prevent movement of the coil. 27. Verify repeatedly that the distal shaft of the delivery pusher is not under stress before coil detachment. Axial compression or tension could cause the tip of the microcatheter to move during coil delivery. Catheter tip movement could cause the aneurysm or vessel to perforate. Tab on introducer sheath Pull shrink-lock proximally Figure 4 Position of Marker Bands for Detachment To minimize the potential risk of aneurysm or vessel perforation DO NOT advance the distal end of the delivery system past the distal tip of the microcatheter. Figure 3 - Pull Shrink Lock Proximally 17. Slowly advance the coil implant out of the introducer sheath and inspect the coil for any irregularities or damage. If any damage to the coil or delivery pusher is observed, DO NOT use the device. INTRODUCTION AND DEPLOYMENT OF THE AZUR SYSTEM 18. Open the RHV on the microcatheter just enough to accept the introducer sheath of the Azur system. 19. Insert the introducer sheath of the Azur system through the RHV. Flush the introducer until it is completely purged of air and saline flush exits the proximal end. 20. Seat the distal tip of the introducer sheath at the distal end of the microcatheter hub and close the RHV lightly around the introducer sheath to secure the RHV to the introducer. Do not over-tighten the RHV around the introducer sheath. Excessive tightening could damage the device. 21. Push the coil into the lumen of the microcatheter. Use caution to avoid catching the coil on the junction between the introducer sheath and the hub of the microcatheter. 22. Push the Azur system through the microcatheter until the proximal end of the delivery pusher meets the proximal end of the introducer sheath. Loosen the RHV. Retract the introducer sheath just out of the RHV. Close the RHV around the delivery pusher. Slide the introducer sheath completely off of the delivery pusher. Use care not to kink the delivery system. 23. At this time, fluoroscopic guidance should be initiated. Depending on length of microcatheter used, fluoroscopy initiation may be delayed to minimize exposure. 24. Under fluoroscopic guidance, slowly advance the coil out the tip of the microcatheter. Continue to advance the coil into the lesion until optimal deployment is achieved. Reposition if necessary. If DETACHMENT OF THE COIL 28. The Azur Detachment Controller is pre-loaded with battery power and will activate when a delivery pusher is properly connected. It is in a power off mode when no delivery pusher is attached. It is not necessary to push the button on the side of the Azur Detachment Controller to activate it. 29. Verify that the RHV is firmly locked around the delivery pusher before attaching the Azur Detachment Controller to ensure that the coil does not move during the connection process. 30. Although the delivery pusher s gold connectors are designed to be compatible with blood and contrast, every effort should be made to keep the connectors free of these items. If there appears to be blood or contrast on the connectors, wipe the connectors with sterile water or saline solution before connecting to the Azur Detachment Controller. 31. Connect the proximal end of the delivery pusher to the Azur Detachment Controller by firmly inserting the proximal end of the delivery pusher into the funnel section of the Azur Detachment Controller. See Figure When the Azur Detachment Controller is properly connected to the delivery pusher, a single audible tone will sound and the light will turn green to signal that it is ready to detach the coil. If the detachment button is not pushed within 30 seconds, the solid green light will slowly flash green. Both flashing green and solid green lights indicate that the device is ready to detach. If the green light does not appear, check to ensure that the connection has been made. If the connection is correct and no green light appears, replace the Azur Detachment Controller. 33. Verify the coil position before pushing the detachment button. 34. Push the detachment button. When the button is pushed, an audible tone will sound and the light will flash green. 35. At the end of the detachment cycle, three audible tones will sound and the light will flash yellow three times. This indicates that the detachment cycle is complete. If the coil does not detach during the detachment cycle, leave the Azur Detachment Controller - 3 -

13 attached to the delivery pusher and attempt another detachment cycle when the light turns green. 36. The light will turn red after the number of detachment cycles specified on the Azur Detachment Controller labeling. DO NOT use the Azur Detachment Controller if the light is red. Discard the Azur Detachment Controller and replace it with a new one when the light is red. 37. Verify detachment of the coil by first loosening the RHV valve, then pulling back slowly on the delivery system and verifying that there is no coil movement. If the implant did not detach, do not attempt to detach it more than two additional times. If it does not detach after the third attempt, remove the delivery system. 38. After detachment has been confirmed, slowly retract and remove the delivery pusher. Advancing the delivery pusher once the coil has been detached involves the risk of aneurysm or vessel rupture. Do NOT advance the delivery pusher once the coil has been detached. 39. Verify the position of the coil angiographically through the guide catheter. 40. Additional coils may be deployed into the lesion as described above. Prior to removing the microcatheter from the treatment site, place an appropriately sized guidewire completely through the microcatheter lumen to ensure that no part of the last coil remains within the microcatheter. The physician has the discretion to modify the coil deployment technique to accommodate the complexity and variation in embolization procedures. Any technique modifications must be consistent with the previously described procedures, warnings, precautions and patient safety information. SPECIFICATIONS FOR AZUR DETACHMENT CONTROLLER Output voltage: 8 ± 1 VDC Cleaning, preventative inspection, and maintenance: The Azur Detachment Controller is a single use device, preloaded with battery power, and packaged sterile. No cleaning, inspection, or maintenance is required. If the device does not perform as described in the Detachment section of these Instructions, discard the Azur Detachment Controller and replace it with a new unit. The Azur Detachment Controller is a single use device. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. Batteries are pre-loaded into the Azur Detachment Controllers. Do not attempt to remove or replace the batteries prior to use. After use, dispose of the Azur Detachment Controller in a manner consistent with local regulations. SHELF LIFE See the product label for the device shelf life. Do not use the device beyond the labeled shelf life. MR INFORMATION The coil implant has been determined to be MR conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F Non-clinical testing demonstrated that the coil implant is MR conditional. A patient can be scanned safely, immediately after placement under the following conditions: Static magnetic field of 3 Tesla or less Maximum spatial gradient field of 720 Gauss/cm or less MRI-Related Heating In non-clinical testing, the coil implant produced a maximum temperature rise of 1.7 C during MRI performed for 15 minutes of scanning in the 3 Tesla (3-Tesla/128-MHz, Excite, HDx, Software 14X.M5, General Electric Healthcare, Milwaukee, WI) MR system. Therefore, the MRI-related heating experiments for the coil implant at 3 Tesla using a transmit/receive RF body coil at an MR system reported whole body averaged SAR of 2.9 W/kg (i.e., associated with a calorimetry measured whole body averaged value of 2.7 W/kg) indicated that the greatest amount of heating that occurred in association with these specific conditions was equal to or less than 1.7 C. Image Artifact Information MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the coil implant. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary. Pulse Sequence: T1-SE T1-SE GRE GRE Plane Orientation: Parallel Perpendicular Parallel Perpendicular Signal Void Size: 511 mm 2 80 mm mm mm 2 Terumo Corporation recommends that the patient register the MR conditions disclosed in this IFU with the MedicAlert Foundation or equivalent organization. MATERIALS The Azur system does not contain latex or PVC materials. SYMBOLS PACKAGING AND STORAGE The Azur system is placed inside a protective, plastic dispenser hoop and packaged in a pouch and unit carton. The Azur system and dispenser hoop will remain sterile unless the package is opened, damaged, or the expiration date has passed. Store at a controlled room temperature in a dry place. The Azur Detachment Controller is packaged separately in a protective pouch and carton. The Azur Detachment Controller has been sterilized; it will remain sterile unless the pouch is opened, damaged, or the expiration date has passed. Store at a controlled room temperature in a dry place. Lot Number Order Number Content Sterilized Using Irradiation Sterilized Using Ethylene Oxide - 4 -

14 Do Not Reuse Use-by Date Distributed by: Terumo Medical Corporation 2101 Cottontail Lane Somerset, NJ Tel: (800) Date of Manufacture Attention, Consult Accompanying Documents Type BF Applied Part Authorized European Representative: MicroVention Europe 30 bis, rue du Vieil Abreuvoir Saint-Germain-en-Laye France Tel: +33 (0) Fax: +33 (0) Power ON and OFF 0297 PD Rev. B Revised CE Mark Manufacturer Authorized European Representative MR Conditional Non-pyrogenic Upper limit of temperature WARRANTY Terumo warrants that reasonable care has been used in the design and manufacture of this device. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for particular purpose. Handling, storage, cleaning, and sterilization of the device as well as factors relating to the patient, diagnosis, treatment, surgical procedure, and other matters beyond Terumo s control directly affect the device and the results obtained from its use. Terumo s obligation under this warranty is limited to the repair or replacement of this device through its expiration date. Terumo shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly arising from the use of this device. Terumo neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this device. Terumo assumes no liability with respect to devices reused, reprocessed or resterilized and makes no warranties, expressed or implied, including, but not limited to, merchantability or fitness for intended use, with respect to such device. Prices, specifications, and model availability are subject to change without notice. Copyright 2012 Terumo Corporation. All rights reserved. Terumo and Azur are registered trademarks of Terumo Corporation. MicroVention is a registered trademark of MicroVention, Inc. Manufacturer: MicroVention, Inc Valencia Avenue Tustin, CA USA Tel: (714)

15 Detachable Instructions for Use PD Rev. A 1 MicroVention, Inc.

16 English Azur CX Peripheral Coil System (Detachable) Instructions for Use DEVICE DESCRIPTION The Detachable Azur CX Peripheral Coil System (Azur system) consists of a coil implant attached to a delivery system. The coils are platinum coils with an inner layer of hydrophilic polymer. The delivery pusher is powered by an Azur Detachment Controller to selectively detach the coils. The Azur Detachment Controller is provided separately. The Azur system is available in a broad range of coil diameters and lengths. The coil must be delivered only through a wire-reinforced microcatheter with the inner diameter specified. Table 1 Coil Type Microcatheter I.D. inches mm Reposition Time Azur Detachable minutes INDICATIONS FOR USE The Azur system is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature. This device should only be used by physicians who have undergone training in the use of the Azur system for embolization procedures as prescribed by a representative from Terumo or a Terumo-authorized distributor. CONTRAINDICATIONS Use of the Azur system is contraindicated in any of the following circumstances: When superselective coil placement is not possible. When end arteries lead directly to nerves. When arteries supplying the lesion to be treated are not large enough to accept emboli. When the A-V shunt is larger than the coil. In the presence of severe atheromatous disease. In the presence of vasospasm (or likely onset of vasospasm). POTENTIAL COMPLICATIONS Potential complications include, but are not limited to: hematoma at the site of entry, vessel/aneurysm perforation, unintended parent artery occlusion, incomplete filling, vascular thrombosis, hemorrhage, ischemia, vasospasm, edema, coil migration or misplacement, premature or difficult coil detachment, clot formation, revascularization, post-embolization syndrome, and neurological deficits including stroke and possibly death. The physician should be aware of these complications and instruct patients when indicated. Appropriate patient management should be considered. REQUIRED ADDITIONAL ITEMS Azur Detachment Controller Wire-reinforced microcatheter with distal tip RO marker, appropriately sized Guide catheter compatible with microcatheter Steerable guidewires compatible with microcatheter 2 rotating hemostatic Y valves (RHV) 1 three-way stopcock Pressurized sterile saline drip 1 one-way stopcock Stopwatch or timer WARNINGS AND PRECAUTIONS Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. The Azur system is supplied sterile and non-pyrogenic unless package is opened or damaged. This device is intended for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. Angiography is required for pre-embolization evaluation, operative control, and post-embolization follow up. Do not advance the delivery pusher with excessive force. Determine the cause of any unusual resistance, remove the Azur system, and check for damage. Advance and retract the Azur system slowly and smoothly. Remove the entire Azur system if excessive friction is noted. If excessive friction is noted with a second Azur system, check the microcatheter for damage or kinking. The coil must be properly positioned in the vessel or aneurysm within the specified reposition time from the time the device is first introduced into the microcatheter. If the coil cannot be positioned and detached within this time, simultaneously remove the device and the microcatheter. Positioning the device in a low-flow environment may increase the reposition time. If repositioning is necessary, take special care to retract the coil under fluoroscopy in a one-to-one motion with the delivery pusher. If the coil does not move in a oneto-one motion with the delivery pusher, or if repositioning is difficult, the coil may have become stretched and could possibly break. Gently remove and discard the entire device. Due to the delicate nature of the coils, the tortuous vascular pathways that lead to certain lesions, and the varying morphologies of the vasculature, a coil may occasionally stretch while being maneuvered. Stretching is a precursor to potential coil breakage and migration. If a coil must be retrieved from the vasculature after detachment, do not attempt to withdraw the coil with a retrieval device, such as a snare, into the delivery catheter. This could damage the coil and result in device separation. Remove the coil, microcatheter, and any retrieval device from the vasculature simultaneously. Delivery of multiple coils is usually required to achieve the desired occlusion of some vasculatures or lesions. The desired procedural endpoint is usually angiographic occlusion. The filling properties of the coils facilitate angiographic occlusion. Tortuosity or complex vessel anatomy may affect accurate placement of the coil. The long-term effect of this product on extravascular tissues has not been established so care should be taken to retain this device in the intravascular space. Always ensure that at least two Azur Detachment Controllers are available before starting an Azur system procedure. The coil cannot be detached with any power source other than an Azur Detachment Controller. Do NOT place the delivery pusher on a bare metallic surface. Always handle the delivery pusher with surgical gloves. Do NOT use in conjunction with radio frequency (RF) devices. PREPARATION FOR USE 1. Refer to Figure 1 for the set-up diagram. 2. Attach a rotating hemostatic valve (RHV) to the hub of the guiding catheter. Attach a 3-way stopcock to the side arm of the RHV and then connect a line for continuous infusion of flush solution. 3. Attach a second RHV to the hub of the microcatheter. Attach a 1-way stopcock to the sidearm of the second RHV and connect the flush solution line to the stopcock. 4. Open the stopcock and flush the microcatheter with sterile flush solution and then close the stopcock. To minimize the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate sterile flush solution be maintained into the guide catheter, the femoral sheath and the microcatheter. CATHETERIZATION OF THE LESION 5. Using standard interventional procedures, access the vessel with a guide catheter. The guide catheter should have an inner diameter (ID) large enough to allow for contrast injection while the microcatheter is in place. This will allow for fluoroscopic road mapping during the procedure. 6. Select a microcatheter with the appropriate inner diameter. After the microcatheter has been positioned inside the lesion, remove the guidewire. COIL SIZE SELECTION 7. Perform fluoroscopic road mapping. 8. Measure and estimate the size of the lesion to be treated. 9. For aneurysm occlusion, the diameter of the first and second coils should never be less than the width of the aneurysm neck or the propensity for the coils to migrate may be increased. 10. For vessel occlusion, select a coil size that is slightly larger than the vessel diameter. 11. Correct coil selection increases effectiveness and patient safety. Occlusive efficiency is, in part, a function of compaction and overall coil mass. In order to choose the optimum coil for any given lesion, examine the pre-treatment angiograms. The appropriate coil size should be chosen based upon angiographic assessment of the diameter of the target or parent vessel, aneurysm dome and aneurysm neck. PD Rev. A 1 MicroVention, Inc.

17 Line to flush solution One-way stopcock Line to flush solution 3-way stopcock Line to flush solution 3-way stopcock RHV RHV Azur delivery pusher proximal end connects to detachment controller Guide catheter Femoral sheath Coil Implant Microcatheter Microcatheter Distal Tip RO marker band Blood vessel Figure 1 Diagram of Azur System Setup PREPARATION OF THE AZUR SYSTEM FOR DELIVERY If the green light remains solid green for the entire three-second observation, continue using the device. 15. Hold the device just distal to the shrink-lock and pull the shrink-lock proximally to expose the tab on introducer sheath. See Figure 3. Indicator Light Tab on introducer sheath Pull shrink-lock proximally Detachment Button Funnel Azur delivery pusher Insertion Direction Figure 2 Azur Detachment Controller Figure 3 Pull Shrink Lock Proximally 12. Remove the Azur Detachment Controller from its protective packaging. Pull the white pull-tab from the side of the detachment controller. Discard the pull-tab and place the detachment controller in the sterile field. The Azur Detachment Controller is packaged separately as a sterile device. Do not use any power source other than the Azur Detachment Controller to detach the coil. The Azur Detachment Controller is intended to be used on one patient. Do not attempt to re-sterilize or otherwise re-use the Azur Detachment Controller. 13. Prior to using the device, remove the proximal end of the delivery pusher from the packaging hoop. Use care to avoid contaminating this end of the delivery pusher with foreign substances such as blood or contrast. Firmly insert the proximal end of the delivery pusher into the funnel section of the Azur Detachment Controller. See Figure 2. Do not push the detachment button at this time. 14. Wait three seconds and observe the indicator light on the detachment controller. If the green light does not appear or if a red light appears, replace the device. If the light turns green, then turns off at any time during the three-second observation, replace the device. 16. Slowly advance the coil out of the introducer sheath and inspect the coil for any irregularities or damage. If any damage to the coil or delivery pusher is observed, DO NOT use the device. 17. With the distal end of the introducer sheath pointed downward, gently retract the implant back completely into the introducer sheath about 1 to 2 cm. INTRODUCTION AND DEPLOYMENT OF THE AZUR SYSTEM 18. Open the RHV on the microcatheter just enough to accept the introducer sheath of the Azur system. 19. Insert the introducer sheath of the Azur system through the RHV. Flush the introducer until it is completely purged of air and saline flush exits the proximal end. 20. Seat the distal tip of the introducer sheath at the distal end of the microcatheter hub and close the RHV lightly around the introducer sheath to secure the RHV to the introducer. Do not over-tighten the RHV around the introducer sheath. Excessive tightening could damage the device. MicroVention, Inc. 2 PD Rev. A

18 21. Push the coil into the lumen of the microcatheter. Use caution to avoid catching the coil on the junction between the introducer sheath and the hub of the microcatheter. Initiate timing using a stopwatch or timer at the moment the device enters the microcatheter. Detachment must occur within the specified reposition time. 22. Push the Azur system through the microcatheter until the proximal end of the delivery pusher meets the proximal end of the introducer sheath. Loosen the RHV. Retract the introducer sheath just out of the RHV. Close the RHV around the delivery pusher. Slide the introducer sheath completely off of the delivery pusher. Use care not to kink the delivery system. To prevent premature hydration of the Azur system, ensure that there is flow from the saline flush. 23. Discard the introducer sheath. The Azur system cannot be re-sheathed after introduction into the microcatheter. 24. At this time, fluoroscopic guidance should be initiated. Depending on length of microcatheter used, fluoroscopy initiation may be delayed to minimize exposure. 25. Under fluoroscopic guidance, slowly advance the coil out the tip of the microcatheter. Continue to advance the coil into the lesion until optimal deployment is achieved. Reposition if necessary. If the coil size is not suitable, remove and replace with another device. If undesirable movement of the coil is observed under fluoroscopy following placement and prior to detachment, remove the coil and replace with another more appropriately sized coil. Movement of the coil may indicate that the coil could migrate once it is detached. DO NOT rotate the delivery pusher during or after delivery of the coil into the vasculature. Rotating the delivery pusher may result in a stretched coil or premature detachment of the coil from the delivery pusher, which could result in coil migration. Angiographic assessment should also be performed prior to detachment to ensure that the coil mass is not protruding into undesired vasculature. 26. Complete the deployment and any repositioning so that the coil will be detached within the reposition time specified in Table 1. After the specified time, the swelling of the hydrophilic polymer may prevent passage through the microcatheter and damage the coil. If the coil cannot be properly positioned and detached within the specified time, simultaneously remove the device and the microcatheter. 27. Advance the coil into the desired site until the radiopaque marker on the delivery pusher is aligned or slightly distal of microcatheter distal tip RO marker, positioning the detachment zone just outside the microcatheter tip. See Figure Tighten the RHV to prevent movement of the coil. 29. Verify repeatedly that the distal shaft of the delivery pusher is not under stress before coil detachment. Axial compression or tension could cause the tip of the microcatheter to move during coil delivery. Catheter tip movement could cause the aneurysm or vessel to perforate. Proximal end of coil is aligned with microcatheter RO tip Coil Implant Microcatheter Distal Tip RO Marker Microcatheter Distal end of delivery pusher Figure 4 Position of Marker Bands for Detachment To minimize the potential risk of aneurysm or vessel perforation DO NOT advance the distal end of the delivery system past the distal tip of the microcatheter. DETACHMENT OF THE COIL 30. The Azur Detachment Controller is pre-loaded with battery power and will activate when a delivery pusher is properly connected. It is in a power off mode when no delivery pusher is attached. It is not necessary to push the button on the side of the Azur Detachment Controller to activate it. 31. Verify that the RHV is firmly locked around the delivery pusher before attaching the Azur Detachment Controller to ensure that the coil does not move during the connection process. 32. Although the delivery pusher s gold connectors are designed to be compatible with blood and contrast, every effort should be made to keep the connectors free of these items. If there appears to be blood or contrast on the connectors, wipe the connectors with sterile water or saline solution before connecting to the Azur Detachment Controller. 33. Connect the proximal end of the delivery pusher to the Azur Detachment Controller by firmly inserting the proximal end of the delivery pusher into the funnel section of the Azur Detachment Controller. See Figure When the Azur Detachment Controller is properly connected to the delivery pusher, a single audible tone will sound and the light will turn green to signal that it is ready to detach the coil. If the detachment button is not pushed within 30 seconds, the solid green light will slowly flash green. Both flashing green and solid green lights indicate that the device is ready to detach. If the green light does not appear, check to ensure that the connection has been made. If the connection is correct and no green light appears, replace the Azur Detachment Controller. 35. Verify the coil position before pushing the detachment button. 36. Push the detachment button. When the button is pushed, an audible tone will sound and the light will flash green. 37. At the end of the detachment cycle, three audible tones will sound and the light will flash yellow three times. This indicates that the detachment cycle is complete. If the coil does not detach during the detachment cycle, leave the Azur Detachment Controller attached to the delivery pusher and attempt another detachment cycle when the light turns green. 38. The light will turn red after the number of detachment cycles specified on the Azur Detachment Controller labeling. DO NOT use the Azur detachment controller if the light is red. Discard the Azur Detachment Controller and replace it with a new one when the light is red. 39. Verify detachment of the coil by first loosening the RHV valve, then pulling back slowly on the delivery system and verifying that there is no coil movement. If the implant did not detach, do not attempt to detach it more than two additional times. If it does not detach after the third attempt, remove the delivery system. 40. After detachment has been confirmed, slowly retract and remove the delivery pusher. Advancing the delivery pusher once the coil has been detached involves the risk of aneurysm or vessel rupture. Do NOT advance the delivery pusher once the coil has been detached. 41. Verify the position of the coil angiographically through the guide catheter. 42. Additional coils may be deployed into the lesion as described above. Prior to removing the microcatheter from the treatment site, place an appropriately sized guidewire completely through the microcatheter lumen to ensure that no part of the last coil remains within the microcatheter. The physician has the discretion to modify the coil deployment technique to accommodate the complexity and variation in embolization procedures. Any technique modifications must be consistent with the previously described procedures, warnings, precautions and patient safety information. SPECIFICATIONS FOR AZUR DETACHMENT CONTROLLER Output voltage: 8 ± 1 VDC Cleaning, preventative inspection, and maintenance: The Azur Detachment Controller is a single use device, preloaded with battery power, and packaged sterile. No cleaning, inspection, or maintenance is required. If the device does not perform as described in the Detachment section of these Instructions, discard the Azur Detachment Controller and replace it with a new unit. The Azur Detachment Controller is a single use device. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. Batteries are pre-loaded into the Azur Detachment Controllers. Do not attempt to remove or replace the batteries prior to use. After use, dispose of the Azur Detachment Controller in a manner consistent with local regulations. PACKAGING AND STORAGE The Azur system is placed inside a protective, plastic dispenser hoop and packaged in a pouch and unit carton. The Azur system and dispenser hoop will remain sterile unless the package is opened, damaged, or the expiration date has passed. Store at a controlled room temperature in a dry place. The Azur Detachment Controller is packaged separately in a protective pouch and carton. The Azur Detachment Controller has been sterilized; it will remain sterile unless the pouch is opened, damaged, or the expiration date has passed. Store at a controlled room temperature in a dry place. SHELF LIFE See the product label for the device shelf life. Do not use the device beyond the labeled shelf life. MR INFORMATION The coil implant has been determined to be MR conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F Non-clinical testing demonstrated that the coil implant is MR conditional. A patient can be scanned safely, immediately after placement under the following conditions: Static magnetic field of 3 Tesla or less Maximum spatial gradient field of 720 Gauss/cm or less PD Rev. A 3 MicroVention, Inc.