BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLUDER BIFURCATED ENDOPROSTHESIS

    MDR report key: 549058 · Received October 13, 2004

    Report

    Report Number
    2953161-2004-00132
    Event Type
    Injury
    Date Received
    October 13, 2004
    Date of Event
    May 26, 2004
    Report Date
    October 12, 2004
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN COMPLETED A PLANNED AORTO-UNI-ILIAC PROCEDURE UTILIZING THE EXCLUDER BIFURCATED ENDOPROSTHESIS AND ASSOCIATED SURGICAL FEMORAL TO FEMORAL CROSSOVER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCLUDER BIFURCATED ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W.L. GORE & ASSOCIATES, INC. WLG325 0330001-11

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention