BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1020592 · Received March 28, 2008

    Report

    Report Number
    2017233-2008-00093
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    November 12, 2005
    Report Date
    March 27, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    MIH
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2005, A TRAUMA PT WAS TREATED WITH A GORE TAG THORACIC ENDOPROSTHESIS. THE PHYSICIAN MEASURED THE INFERIOR AORTIC DIAMETER AT 20 MM. THE PHYSICIAN USED A TG2610 AND WAS AWARE OF THE EXCESSIVE OVERSIZING OF THE DEVICE, BUT THE TG2610 WAS THE ONLY ENDOPROSTHESIS AVAILABLE FOR THE TRAUMA PT. THE PHYSICIAN DECIDED TO IMPLANT. A DEVICE COLLAPSE WAS NOTICED AT THE 8 MONTH FOLLOW-UP ON NOVEMBER 11, 2005. THE PT UNDERWENT A REINTERVENTION ONE DAY LATER. THE GORE DEVICE WAS EXPLANTED AND THE PT RECEIVED A SURGICAL GRAFT. THE PT IS REPORTED TO BE WELL. NO FILMS ARE AVAILABLE FOR EVALUATION. THE DEVICE WAS EXPLANTED AND DISCARDED AT THE FACILITY.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention