BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1140249 · Received August 29, 2008

    Report

    Report Number
    2017233-2008-00546
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    July 14, 2008
    Report Date
    August 29, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. A REVIEW OF THE MFG RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IN 2008, A PT WAS TREATED WITH A GORE TAG THORACIC ENDOPROSTHESIS IN THE DISTAL AORTIC ARCH. THE PHYSICIAN INTENTIONALLY PERFORMED A COIL EMBOLIZATION OF THE LEFT SUBCLAVIAN ARTERY AND PERFORMED A LEFT COMMON CAROTID ARTERY-LEFT SUBCLAVIAN ARTERY BYPASS. THE PHYSICIAN PERFORMED REPEATED BALLOON MANIPULATION TO THE DEVICE, IN ATTEMPT TO STOP THE PERSISTENT ENDOLEAK. THE ENDOLEAK CONTINUED AND SO THE PHYSICIAN SIMULTANEOUSLY INFLATED A 30 MM HOPKINTON BALLOON AND 25 MM MAXI BALLOON, AND STOPPED THE ENDOLEAK. THE PT SUFFERED STROKE, PARALYSIS ON THE RIGHT SIDE OF THE BODY, AND APHASIA AFTER THE PROCEDURE. AS OF 2008, THE PT CONTINUES TO SUFFER PARALYSIS AND APHASIA, BUT IS IN STABLE CONDITION. PT IS UNDERGOING REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES WLG326 05941687

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other