BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLUDER BIFURCATED ENDOPROSTHESIS

    MDR report key: 538986 · Received August 12, 2004

    Report

    Report Number
    2953161-2004-00062
    Event Type
    Injury
    Date Received
    August 12, 2004
    Date of Event
    July 13, 2004
    Report Date
    August 12, 2004
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EBE DEVICE WAS EXPLANTED. THE REASON GIVEN FOR EXPLANT WAS ANEURYSM GROWTH WITHOUT IDENTIFIABLE ENDOLEAK. AFTER OPENING THE ANEURYSM SAC, WITHOUT CLAMPING THE PROXIMAL AORTA, NO ENDOLEAK WAS FOUND AND THE DEVICE WAS WORKING WELL. THERE WERE NO COMPLICATIONS TO RETRIEVE THE DEVICE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EXAMINATION IN AUGUST 2004.

    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 992910508

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other