—#117653

Product

Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps prevent the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to: Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD. Improve blood flow to the extremity.

FDA product code: NIU — Stent, Superficial Femoral Artery, Drug-Eluting
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P100022
Affected lot / code info: REF ZIV6-35-125-7-80-PTX ; UDI 10827002248950 all lots distributed through 4/16/13

Why it was recalled

Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation

Root cause (FDA determination)

Process control

Action the firm took

Cook Medical sent an Urgent Medical Device Recall letter dated April 24, 2013 to all affect customers. The letter identified the affected products, description of the problem, and actions to be taken. The letter instructed customers to stop use, quarantine, and return all affected products. Customers were asked to complete product reply form and return affected products for credit to Cook Medical, ATTN: Retrun Goods/RGA # 2013C0003. For questions contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235.

Recalling firm

Firm: Cook, Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia

Timeline

Recall initiated: 2013-04-18
Posted by FDA: 2013-05-15
Terminated: 2013-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117653. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.