BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1201370 · Received October 15, 2008

    Report

    Report Number
    2953161-2008-00304
    Event Type
    Death
    Date Received
    October 15, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 15, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE NOTE ADDITIONAL DEVICES IMPLANTED: TG3420/05573313, PXC141000/05866824, TG3420/05552767.

    Description of Event or Problem · 1

    IN 2008, THE PT PRESENTED WITH A RUPTURED THORACIC ANEURYSM AND WAS IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESES. DURING THE PROCEDURE, THE LEFT ILIAC ARTERY WAS RUPTURED. THE DIAMETER OF THE LEFT ILIAC ARTERY WAS 7-8 MM. THE SHEATH INSERTED WAS A COOK 24 FRENCH SHEATH. TWO GORE EXCLUDER AAA ENDOPROSTHESIS WERE IMPLANTED TO REPAIR THE RUPTURED ILIAC ARTERY. THE PT EXPIRED BEFORE THE PROCEDURE WAS COMPLETED. FURTHER INVESTIGATION PER CAUSE OF DEATH IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES WLG325 05611948

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death