0000014166 00000 n 0000001343 00000 n Recall of a specific lot of the self-expanding peripheral stent Protégé EverFlex of the US manufacturer ev3 Inc. due to mislabelling. Update my browser now. Multiple peripheral artery stent, bare-metal (6) FDA Product Code Name. For more information, please call Medtronic at (877) 526-7890. Medtronic Ev3 Everflex Self-Expanding Peripheral Stent W Entrust Delivery System, 8mm, 5f. Peripheral and Biliary Stents 0000008090 00000 n 0000023554 00000 n ev3 also obtained CE Mark for the EverFlex for general use in the peripheral vasculature, including the iliac, subclavian and superficial femoral artery. The EverFlex stent, which is deliverable through a 6 F catheter, offers superior durability, strength, and precise placement. The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6 F, 0.035” over-the-wire delivery system. Indications, Safety, and Warnings. The Protégé EverFlex Self-Expanding Stent System employs the latest nitinol self-expanding stent technology to provide previously undemon-strated durability. ev3 also obtained CE Mark for the EverFlex for general use in the peripheral vasculature, including the iliac, subclavian and superficial femoral artery. Description: EXP. 0000032684 00000 n Indication: The EverFlex™ self-expanding peripheral stent system is intended to improve luminal diameter in the treatment of symptamotic de novo or restenotic lesions up to 180 mm in length in the native superficial femoral artery and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 mm – 7.5 mm. Address: 3033 Campus Drive, Suite #N550, Plymouth, MN 55441 Approval Date: October 10, 2014 With an updated browser, you will have a better Medtronic website experience. EverFlex™ Self-Expanding Peripheral Stent System"; ev3 Inc., February 21, 2008. EV3, INC (6) Brand Name. The EverFlex stent has been available in the United States since February 2006 for the palliative treatment of malignant neoplasms in the biliary tree. DUBLIN -- The EverFlex(TM) self-expanding peripheral stent system from Medtronic plc has proven to provide sustained patency in the treatment of long, complex lesions in the superficial femoral (SFA) and popliteal arteries, according to the three-year results of the DURABILITY II study, which are reported in the recent issue of Catheterization and Cardiovascular Intervention. Recall Protégé EverFlex, ev3. Low profile (5 F) delivery system may allow for smaller puncture site, less time applying pressure,1 quicker ambulatory rates,2 and reduced vascular access complications.3,4 0000005468 00000 n Packaging has been opened. EV3 PROTÉGÉ EverFlex El stent vascular periférico PROTÉGÉ EverFlex, autoexpandible, es un stent con un único diseño celular tipo TransTaper en aleación niquel-titanio NITINOL, Las celdas se encuentran unidas de manera helicoidal que confiere una flexibilidad extrema ideal para zonas de flexión. The Protégé EverFlex Self-Expanding Stent System employs the latest nitinol self-expanding stent technology to provide previously undemon-strated durability. 14 Stores, One Shopping Cart. 0000008353 00000 n Contraindications: Use of the EverFlex self-expanding peripheral stent system is contraindicated in patients with known hypersensitivity to nickel titanium and in patients contraindicated for anticoagulant and/or antiplatelet therapy, patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system. Address: 3033 Campus Drive, Suite #N550, Plymouth, MN 55441 Approval Date: October 10, 2014 EV3 Protege® EverFlex® Self-Expanding Biliary System - PRB35-05-080-120 Stent SE de Vende - DOTmed Lista #2128386: 6FrUsable Shaft Length: 120cmStent Size Diameter: 5mmStent Lenght: 80mmLumen Diameter: 3.5-4.5mmGuidewire: 0.35 inSterileSingle Use Only1 pc EV3 Inc. EverFlex Self-Expanding Biliary Stent Systems Recalled by the FDA The notice from the FDA can be read here. The EverFlex Self-Expanding Stent System is indicated in the United States for the palliative treatment of malignant neoplasms in the biliary tree. Product Name: EverFlex Self-Expanding Peripheral Stent System Manufacturer: ev3, Inc. Recall of a specific lot of the self-expanding peripheral stent Protégé EverFlex of the US manufacturer ev3 Inc. due to mislabelling. Medtronic, EV3. Design of EverFlex Self-expanding Peripheral Stent with Entrust Delivery System. The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6F, 0.035” over-the-wire delivery system. Protege EverFlex Self-Expanding Stent Covidien and ev3 Inc., www.ev3.net Read our privacy statement to learn more. Note: Safety information provided is for the United States. Ev3 is conducting a voluntary recall on three lots of the prot¿g¿ everflex" biliary stent system. 0000001734 00000 n See the Instructions for Use provided with the product for a complete list of warnings, precautions, adverse events and device information. 0000011131 00000 n Cardiovascular 0000003111 00000 n 0000036276 00000 n Recall Protégé EverFlex, ev3. This study investigated the results with primary stenting using the Protégé EverFlex 200-mm-long self-expanding nitinol stent (ev3 Endovascular Inc, Plymouth, Minn) in femoropopliteal TransAtlantic Inter-Society Consensus (TASC) C and D lesions of at least 150 mm in length. trailer <]>> startxref 0 %%EOF 21 0 obj<>stream ev3 has already begun commercial release throughout Europe. Gældende for en samlet stentlængder på op til 200 mm. PROTÉGÉ™ EverFlex™ is a superb next generation stent with an outstanding combination of strength, flexibility and durability. February 21, 2008 --- "Commercial Approval" field - Added CE Mark for general use … Note: Safety information provided is for the palliative treatment of malignant neoplasms in the biliary tree Protégé™. Self-Expanding nitinol stent System ( x ) All items listed are on inventory EverFlex '' biliary stent Recalled... Devices to sale by or on the order of a specific lot of the manufacturer! 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