BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT

    MDR report key: 1082245 · Received July 23, 2008

    Report

    Report Number
    2183870-2008-00097
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    STENTING OF THE POPLITEAL: THE PT PRESENTED 10 MONTHS POST IMPLANT OF THE STENT IN THE POPLITEAL ARTERY WITH ISCHEMIC LOWER LEG. ANGIOPLASTY REVEALED A FRACTURED STENT AND THE PT UNDERWENT BYPASS SURGERY TO THE LOWER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT FGE EV3 INC. PRB35-06-150-120 2927448

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention