BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE STENT

    MDR report key: 592066 · Received June 7, 2004

    Report

    Report Number
    2134479-2004-00006
    Event Type
    Malfunction
    Date Received
    June 7, 2004
    Date of Event
    May 6, 2004
    Report Date
    June 3, 2004
    Manufacturer
    EV3 INC
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS A LIMB SALVAGE CASE. THE DEVICE WAS HALF DEPLOYED IN THE SFA WHEN THE CATHETER SIEZED UP. THE INNER AND OUTER OF THE DELIVERY SYSTEM SEIZED. THE PHYSICIAN THEN AT A LAST RESORT PULLED THE WHOLE SYSTEM OUT AND STOPPED. THE PT WILL NEED SURGICAL INTERVENTION TO REMOVE STENT FRAGMENTS. THE PHYSICIAN FEELS THE CATHETER STRETCHES AND THIS IS A BIG PROBLEM. ADD'L INFO REC'D FIVE DAYS LATER VIA PHONE CALL: SURGICAL INTERVENTION: OPEN THE GROIN AREA AND INTEGRATE, THEN OPEN VESSELS AND EITHER STENT THE PIECES THAT DISLODGED FROM THE STENT OR REMOVE THE STENT FRAGMENTS AND RE-STENT TO SALVAGE THE LIMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE STENT BILIARY STENT SYSTEM FGE EV3 INC SE7-7-150-120 141422

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention AMPLATZ SUPER STIFF GUIDEWIRE 300.