BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER THORACIC ENDOPROSTHESIS

    MDR report key: 883331 · Received July 18, 2007

    Report

    Report Number
    2953161-2007-00115
    Event Type
    Injury
    Date Received
    July 18, 2007
    Date of Event
    June 16, 2007
    Report Date
    July 17, 2007
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS FUNCTIONING IN THE PATIENT. A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED. PLEASE NOTE: IN 2004, FOUR GORE EXCLUDER THORACIC ENDOPROSTHESES WERE IMPLANTED: PB371010 / LOT# 0114407-04 / PB341010 / LOT# 0111704-10; PB311010 / LOT# 0111401-03; AND PB311010 / LOT# 0106001-02 / REGISTRATION # 2953161. ON 6/16/2007 TWO GORE TAG THORACIC ENDOPROSTHESES WERE IMPLANTED: TG3715 / LOT# 04370867 AND TG3715 / LOT# 04708393.

    Description of Event or Problem · 1

    IN 2004, FOUR GORE EXCLUDER THORACIC ENDOPROSTHESES WERE IMPLANTED TO REPAIR AN ACUTE DISSECTION AND POSSIBLE CONTAINED RUPTURE. THE WIRE FRAME FRACTURED ON ONE GORE EXCLUDER THORACIC ENDOPROSTHESIS AND CREATED A HOLE IN THE GRAFT MATERIAL. A SIGNIFICANT TYPE III ENDOLEAK WAS IDENTIFIED. FOUR MONTHS LATER, THE PREVIOUSLY IMPLANTED DEVICES WERE RE-LINED WITH TWO GORE TAG THORACIC ENDOPROSTHESES AND THE TYPE III ENDOLEAK WAS SUCCESSFULLY REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER THORACIC ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W. L. GORE & ASSOCIATES, INC. WLG326 011440704

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention