BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1060303 · Received June 12, 2008

    Report

    Report Number
    2017233-2008-00323
    Event Type
    Death
    Date Received
    June 12, 2008
    Date of Event
    May 4, 2008
    Report Date
    June 11, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. DEATH.

    Description of Event or Problem · 1

    THIS PT WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESES FOR A DESCENDING THORACIC ANEURYSM. PRIOR TO IMPLANT, THE PT HAD A SPINAL DRAIN PLACED. POST-PROCEDURE, THE SPINAL DRAIN WAS REPLACED WITH A NEW DRAIN. POST-OPERATIVELY THE PT EXPERIENCED ANEMIC SYMPTOMS AND BILATERAL LEG WEAKNESS, WHICH WAS ATTRIBUTED TO A PROBABLE ISCHEMIC INJURY OF THE THORACIC SPINE WITH PARTIAL PARALYSIS. ABOUT 2 WEEKS LATER, THE PT PRESENTED WITH A FEVER WHICH STABILIZED WITH MEDICATION. LATER THAT DAY, THE PT EXPIRED DUE TO CARDIAC ARREST AND RESPIRATORY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES, INC. WLG326 04979359

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death