BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLUDER BIFURCATED ENDOPROSTHESIS

    MDR report key: 494703 · Received November 10, 2003

    Report

    Report Number
    2953161-2003-00054
    Event Type
    Injury
    Date Received
    November 10, 2003
    Date of Event
    October 8, 2003
    Report Date
    November 7, 2003
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING THE IMPLANT PROCEDURE OF THE EXCLUDER BIFURCATED ENDOPROSTHESIS (EBE), THE PT RECEIVED 3 UNITS OF BLOOD BECAUSE OF A LEAK AT THE SHEATH SITE.

    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 030491401

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention