BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1130458 · Received August 20, 2008

    Report

    Report Number
    2017233-2008-00492
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 25, 2008
    Report Date
    August 20, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2008, PT WAS IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESIS. AT APPROX 4 MONTHS LATER, A COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED AN ENDOLEAK. A RE-INTERVENTION OCCURRED ABOUT ONE MONTH LATER WITH A GORE TAG THORACIC ENDOPROSTHESIS, IMPLANTED TO RESOLVE ENDOLEAK. PT TOLERATED THE RE-INTERVENTION.

    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 05179603

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention