BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5117049 · Received October 1, 2015

    Report

    Report Number
    2017233-2015-00666
    Event Type
    Injury
    Date Received
    October 1, 2015
    Date of Event
    February 2, 2012
    Report Date
    September 2, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TGT3415/9479225 = UDI:(B)(4). TGT2810/9121950 = UDI:(B)(4). THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING GORE TAG THORACIC ENDOPROSTHESES TO REPAIR AN AORTIC DISSECTION EXTENDING FROM DISTAL TO THE LEFT SUBCLAVIAN ARTERY TO PROXIMAL TO THE Y-SHAPED GRAFT OF THE ABDOMINAL AORTA. PRIOR TO THE DEVICE IMPLANT, DEBRANCHING SURGERY WAS PERFORMED FROM THE ASCENDING AORTA TO BRACHIOCEPHALIC, LEFT COMMON CAROTID, AND LEFT SUBCLAVIAN ARTERIES. ON AN UNKNOWN DATE AFTER THE PROCEDURE, THE PATIENT DEVELOPED PARAPARESIS. THE CAUSE OF THE PARAPARESIS WAS UNKNOWN. IT WAS UNKNOWN WHAT TREATMENT WAS ADMINISTERED TO TREAT THE PARAPARESIS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650850 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9479225

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability TGT2810/9121950