BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER THORACIC ENDOPROSTHESIS

    MDR report key: 1812204 · Received August 19, 2010

    Report

    Report Number
    2017233-2010-00373
    Event Type
    Injury
    Date Received
    August 19, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 19, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS- THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE SAFETY AND EFFECTIVENESS OF THE GORE TAG THORACIC ENDOPROSTHESIS HAS NOT BEEN EVALUATED IN PATIENT POPULATIONS INCLUDING INTRAMURAL HEMATOMAS AND PENETRATING ULCERS.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THIS PATIENT WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESIS TO TREAT AN INTRAMURAL HEMATOMA. ON (B)(6) 2010, THIS PATIENT UNDERWENT A REINTERVENTION USING GORE TAG THORACIC ENDOPROSTHESIS TO TREAT PROGRESSION OF A PENETRATING ULCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG326 05025384

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R