BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE

    MDR report key: 2213804 · Received March 28, 2008

    Report

    Report Number
    MW5021732
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 28, 2008
    Manufacturer
    W L GORE & ASSOCIATES
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MAL DEPLOYMENT OF VIABAHN STENT INTO LEFT FEMORAL ARTERY. THIS RESULTED IN ISCHEMIA TO LLE AND SURGICAL INTERVENTION TO REMOVE (7FR 6MM X 15CM). SALES REP AWARE OF ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE VIABAHN ENDOVASCULAR PROSTHESIS NIP W L GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention