BEUDAMED
    FDA Enforcement Class I Terminated

    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.

    Recall: Z-1275-2013 · Reported May 22, 2013

    Enforcement

    Recall Number
    Z-1275-2013
    Event ID
    64975
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2013
    Initiation Date
    April 18, 2013
    Classification Date
    May 15, 2013
    Termination Date
    December 5, 2013
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120, United States

    Description

    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.

    Reason

    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

    Code Info

    REF ZIV6-35-125-7-80-PTX ; UDI 10827002248950 all lots distributed through 4/16/13

    Distribution

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

    Quantity

    535 units in USA