BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1020374 · Received March 28, 2008

    Report

    Report Number
    2017233-2008-00128
    Event Type
    Death
    Date Received
    March 28, 2008
    Date of Event
    February 14, 2008
    Report Date
    March 28, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    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 MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. TORTUOSITY.

    Description of Event or Problem · 1

    AS REPORTED, IN 2008, THIS PT WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESES FOR A DESCENDING THORACIC ANEURYSM. THE PT'S ANATOMY WAS VERY TORTUOUS. THE FIRST TWO ENDOPROSTHESES IMPLANTED WITHOUT DIFFICULTY. THE THIRD DEVICE WOULD NOT ADVANCE INTO THE AORTA DUE TO THE TORTUOUS ANATOMY. THE PHYSICIAN ATTEMPTED TO RETRACT THE ENDOPROSTHESIS OUT OF THE GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE BUT THE DEVICE WOULD NOT RETRACT. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE ENDOPROSTHESIS AND SHEATH SIMULTANEOUSLY BUT THE DEVICE BEGAN TO DEPLOY WITHIN THE PREVIOUSLY IMPLANTED ILIO-FEMORAL GRAFT. THE PHYSICIAN HAD TO DISASSEMBLE THE DEVICE IN ORDER TO REMOVE IT. TWO GORE TAG THORACIC ENDOPROSTHESES WERE THEN ADVANCED AND SUCCESSFULLY IMPLANTED IN THE PT. THE PT LEFT THE OPERATING ROOM IN STABLE CONDITION. LATER THAT EVENING, THE PT EXPIRED DUE TO SUSPECTED DISRUPTION OF THE ILIO-FEMORAL GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W.L. GORE & ASSOCIATES, INC. WLG326 05501671

    Patients

    Seq Age Sex Outcome Treatment
    1 Death