BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3230017 · Received July 11, 2013

    Report

    Report Number
    2017233-2013-00453
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    October 28, 2009
    Report Date
    July 8, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THIS PATIENT UNDERWENT EMERGENCY REPAIR OF A THORACIC AORTIC ANEURYSM USING GORE TAG THORACIC ENDOPROSTHESIS. ON (B)(6) 2009, A PROXIMAL TYPE 1 ENDOLEAK WAS SEEN ON IMAGING. AN INTERVENTION OCCURRED WHEREBY A STENT GRAFT OF UNKNOWN MANUFACTURE WAS IMPLANTED. ON (B)(6) 2009, THE PATIENT EXPIRED OF HEMORRHAGIC STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320764 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7001095

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| H| R