BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1078233 · Received July 17, 2008

    Report

    Report Number
    2017233-2008-00382
    Event Type
    Death
    Date Received
    July 17, 2008
    Date of Event
    June 19, 2008
    Report Date
    July 16, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED.

    Description of Event or Problem · 1

    IN 2008, THIS PATIENT WAS IMPLANTED WITH FOUR GORE TAG THORACIC ENDOPROSTHESES, STARTING FROM THE LEFT CAROTID ARTERY TO THE LEVEL OF THE CELIAC ARTERY. THE PROXIMAL END OF THE MOST PROXIMAL DEVICE COLLAPSED. THE PHYSICIAN TRIED TO RE-OPEN THE PROXIMAL END OF THE DEVICE USING FOUR GORE TRI-LOBE BALLOON CATHETERS AND A CODA BALLOON CATHETER THAT ALL RUPTURED. FINALLY, THE PHYSICIAN WAS ABLE TO RE-OPEN THE PROXIMAL DEVICE WITH AT Z-MED II. THE PATIENT SUFFERED CEREBELLAR STROKE AND ACUTE RENAL FAILURE AND WAS ELECTED TO PROCEED WITH COMFORT CARER AND EXPIRED ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES WLG326 04347479

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death