Balloon Expandable Biliary Stent Instructions for Use - eV3

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STENT AND PTA BALLOON CATHETER ASSEMBLY PREPARATION 1. Select a stent and non-compliant PTA balloon dilation catheter for the duct into which the stent will be implanted. The nominal diameter of the balloon should approximate the diameter of the obstructed duct and intended implant site. NOTE: Use a balloon that requires a 7 Fr or a larger sheath. A smaller balloon may not have a large enough diameter to allow optimal crimping of the stent to the balloon. 2. Remove the stent from the package and rinse in sterile saline. 3. Remove the balloon catheter from the sterile package in preparation for stent mounting. 4. Preinflate the balloon to ensure the balloon opens uniformly. 5. Refold the balloon per manufacturer’s instructions. 6. Visually inspect the balloon to assure that it is properly folded to its lowest profile before stent application. 7. If balloon has a lubricious coating, use a saline saturated sterile gauze to gently wipe the folded balloon to reduce the lubricious coating. 8. Carefully insert the distal tip of the unexpanded balloon, while maintaining balloon fold into the angled end of the stent mounting tube (Figure 1.) 9. While holding the cap of the mounting tube, gently pinch the mounting tube behind the stent and slide the stent onto the balloon. (Figure 2). Do not compress the stent on the mounting tube. This may potentially crimp the stent to the mounting tube (Figure 2a). 10. Continue to slide the stent over the balloon while using the balloon radiopaque markers for centering the balloon (Figure 3). 11. Gently using the thumbs and index fingers of both hands, crimp the stent onto the balloon from all directions to ensure full adherence of the stent to the balloon. 12. Flush the balloon catheter lumen with saline, then load the stent/delivery assembly onto the guidewire. 13. Apply a pressure of one atmosphere to the balloon to slightly preinflate both balloon cones. 14. Verify both balloon cones are slightly inflated. 15. Maintain this low pressure during insertion of the stent/delivery assembly. STENT/DELIVERY ASSEMBLY INSERTION 1. The stent/delivery assembly is advanced through the appropriate sized sheath, over the guidewire into correct position. If a hemostatic valve is present on the introducer sheath, a metal introducer tube can be used to facilitate advancement of the stent. 2. Position the stent across the target stricture. The distal portion of the stent should be positioned so that it completely covers the distal extent of the stricture. NOTE: Care should be taken to fully cover the area proximal and distal to an inoperable malignant tumor with the stent to protect against impingement from further tumor growth. 3. Pull back on the sheath to fully expose the stent. Expand the stent by inflating the balloon catheter to the nominal inflation pressure. Appropriate expansion of the balloon/stent should be determined using fluoroscopy. Do not exceed the balloon catheter manufacturer’s recommended maximum balloon inflation pressure. 4. The diameter of the stent can be sized to the lumen of the bile duct. 5. Deflate the balloon. 6. Rotate the deflated balloon delivery catheter to ensure the stent is free and properly deployed. 7. Remove the delivery catheter. Page 2 45-2344-000, C FEB/05 2 1 2a 3
PRODUCT STENT SIZE EXPANDED STENT RECOMMENDED CODE UNMOUNTED DIMENSIONS BALLOON CATHETER DIAMETER LENGTH DIAMETER LENGTH DIAMETER/LENGTH (mm) (mm) (mm) (mm) (mm)/(cm) S17-16 3.8 16.0 9.0 16.0 9.0/2.0 10.0 10.0/2.0 12.0 12.0/2.0 S17-26 3.8 26.0 9.0 26.0 9.0/3.0 10.0 10.0/3.0 12.0 12.0/3.0 S17-36 3.8 36.0 9.0 36.0 9.0/4.0 10.0 10.0/4.0 12.0 12.0/4.0 S18-16 4.5 16.0 12.0 16.0 12.0/2.0 S18-26 4.5 26.0 12.0 26.0 12.0/3.0 S18-36 4.5 36.0 12.0 36.0 12.0/4.0 CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. WARRANTY DISCLAIMER Although this product has been manufactured under carefully controlled conditions, ev3 Inc. has no control over the conditions under which this product is used. ev3 Inc. therefore disclaims all warranties, both express and implied, with respect to the product including, but not limited to, any implied warranty of merchantability or fitness for a particular purpose. ev3 Inc. shall not be liable to any person or entity for any medical expenses or any direct, incidental or consequential damages caused by any use, defect, failure or malfunction of the product, whether a claim for such damages is based upon warranty, contract, tort or otherwise. No person has any authority to bind ev3 Inc. to any representation or warranty with respect to the product. The exclusions and limitations set out above are not intended to, and should not be construed so as to contravene mandatory provisions of applicable law. If any part or term of this Disclaimer of Warranty is held to be illegal, unenforceable or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of this Disclaimer of Warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this Disclaimer of Warranty did not contain the particular part or term held to be invalid. 4600 Nathan Lane North Plymouth, MN 55442-2920 USA PH: 763.398.7000 800.716.6700 FX: 763.398.7200 ©2005 ev3 Inc. All rights reserved. Printed in the U.S.A. T H E E N D O V A S C U L A R C O M P A N Y IntraStent, Mega and Max are trademarks of ev3 Inc. Protected under one or more of the following: US Patent 6,827,732; 6,558,415; 6,358,274; 6,254,631; 6,132,460. Non-US patents pending. Page 3 45-2344-000, C FEB/05
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Balloon Expandable Biliary Stent Instructions for Use - eV3

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