BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1000177 · Received February 18, 2008

    Report

    Report Number
    2017233-2008-00071
    Event Type
    Injury
    Date Received
    February 18, 2008
    Date of Event
    September 21, 2007
    Report Date
    February 15, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IN 2007, A GORE TAG THORACIC ENDOPROSTHESIS WAS IMPLANTED. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED IN A POOR LOCATION AND THAT THE DEVICE DID NOT HAVE INNER CURVE WALL APPOSITION. ON THE FOLLOWING MONTH, THE DEVICE COLLAPSED. A MEDTRONIC TALENT THORACIC STENT GRAFT WAS IMPLANTED AND THE COLLAPSED DEVICE WAS REPAIRED. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE.

    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 05201658

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention