BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER THORACIC ENDOPROSTHESIS

    MDR report key: 1970669 · Received January 19, 2011

    Report

    Report Number
    2017233-2011-00028
    Event Type
    Death
    Date Received
    January 19, 2011
    Date of Event
    August 20, 2008
    Report Date
    January 18, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE PT HAD BEEN TRANSFERRED EMERGENTLY FROM ANOTHER FACILITY AND PRESENTED WITH A TYPE B DISSECTION AND MESENTERIC ISCHEMIA.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PT HAD BEEN TRANSFERRED EMERGENTLY FROM ANOTHER FACILITY AND PRESENTED WITH A TYPE B DISSECTION AND MESENTERIC ISCHEMIA. THE PT WAS SEVERELY ACIDOTIC AND CONTINUED TO EXPERIENCED A DROP IN BLOOD PRESSURE. AFTER THE GORE TAG ENDOPROSTHESIS WAS IMPLANTED, COLO-RECTAL SURGERY WAS INITIATED AND FURTHER ISCHEMIA WAS APPRECIATED. THE PT WAS CLOSED AND THE FAMILY REQUESTED COMFORT MEASURES BE UNDER TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG326 05845197

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death