BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1242879 · Received November 24, 2008

    Report

    Report Number
    2017233-2008-00905
    Event Type
    Death
    Date Received
    November 24, 2008
    Date of Event
    October 7, 2007
    Report Date
    November 24, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 DEVICE IMPLANTED: TG4020/04284290.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH A RUPTURED ANEURYSM AND WAS IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESES IN 2007. THE PATIENT TOLERATED THE PROCEDURE. THE FOLLOWING MONTH, THE PATIENT EXPIRED. CAUSE OF DEATH WAS COLON ISCHEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES WLG326 04284290

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death