BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1201454 · Received October 16, 2008

    Report

    Report Number
    2017233-2008-00742
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    September 21, 2008
    Report Date
    October 15, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AS REPORTED, IN 2008, THIS PATIENT SUSTAINED MULTI-SYSTEM TRAUMA SECONDARY TO A MOTOR VEHICLE ACCIDENT AND UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC TRANSECTION USING A GORE TAG THORACIC ENDOPROSTHESIS. COMPLETION ANGIOGRAPHY REVEALED THAT THE GRAFT HAD POOR PROXIMAL WALL APPOSITION; HOWEVER, NO EXTRAVASATION OF CONTRAST THROUGH THE LESION WAS NOTED, SO IT WAS DECIDED TO LEAVE THE GRAFT AS IS. A FOLLOW-UP CTA TAKEN THREE DAYS LATER, SHOWED INVAGINATION OF THE GRAFT AT THE PROXIMAL END. A REINTERVENTION TOOK PLACE THE FOLLOWING DAY. BALLOONING THE DEVICE WITH A GORE TRI-LOBE BALLOON CATHETER WAS ATTEMPTED, BUT THE BALLOON RUPTURED AND THE DEVICE CONTINUED TO COLLAPSE. AN ADDITIONAL GORE TAG THORACIC ENDOPROSTHESIS WAS THEN PLACED PROXIMALLY, INTENTIONALLY COVERING THE LEFT SUBCLAVIAN ARTERY, WITH MINOR POOR WALL APPOSITION NOTED. A CORDIS PALMAZ STENT WAS, THEREFORE, IMPLANTED USING A COOK CODA BALLOON CATHETER. FULL WALL APPOSITION WAS OBTAINED ALONG WITH CONTINUED FILLING OF THE LEFT CAROTID ARTERY AND LEFT SUBCLAVIAN ARTERY. NO FURTHER EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES WLG326 06225366

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention