BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1151436 · Received September 5, 2008

    Report

    Report Number
    2017233-2008-00575
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 7, 2008
    Report Date
    September 7, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    IN 2008, THIS PT WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESIS IN THE DISTAL AORTIC ARCH INTENTIONALLY COVERING THE LEFT SUBCLAVIAN ARTERY AND LEFT CAROTID ARTERY. POST-OPERATIVELY, THE PT DEVELOPED MULTIPLE CEREBELLAR INFARCTION, MINOR DISTURBANCE OF CONSCIOUSNESS, AND AGNOSIS. THE PT HAS BEEN DISCHARGED.

    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 05861493

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other