BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1130447 · Received August 19, 2008

    Report

    Report Number
    2017233-2008-00474
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    July 22, 2008
    Report Date
    August 18, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: THE PHYSICIAN INTENTIONALLY COVERED THE CAROTID ARTERY.

    Description of Event or Problem · 1

    AS REPORTED, IN 2008, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING GORE TAG THORACIC ENDOPROSTHESES. A GORE TRI-LOBE BALLOON CATHETER WAS REINTRODUCED TO ATTEMPT TO SEAL A LEAK. UPON INSERTION, THE BALLOON CATHETER PUSHED ONE OF THE DEVICES INTO THE PATIENT'S ASCENDING AORTIC ARCH, UNINTENTIONALLY COVERING THE LEFT INNOMINATE ARTERY. THE PHYSICIAN CHOSE TO BRIDGE THE TWO GRAFTS WITH AN ADDITIONAL ENDOPROSTHESIS, AND AN INNOMINATE ARTERY BYPASS WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W.L. GORE & ASSOCIATES WLG326 04666330

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention