BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS

    MDR report key: 13314805 · Received January 21, 2022

    Report

    Report Number
    2017233-2022-02683
    Event Type
    Death
    Date Received
    January 21, 2022
    Date of Event
    December 21, 2021
    Report Date
    January 21, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CODE (B)(4): THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN AORTIC ARCH ANEURYSM USING CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS. AFTER 3 DEBRANCH BYPASS FOR THE AORTIC ARCH BRANCH VESSELS WAS PERFORMED, CTAG WAS ADVANCED RETROGRADE INTO THE ASCENDING AORTA AND DEPLOYED IN ZONE 0. NO LEAK WAS DETECTED AND THE DEVICE IMPLANTATION WAS COMPLETED. DURING THE WOUND CLOSURE, DECREASED HEART FUNCTION WAS CONFIRMED. THE PATIENT WAS REOPENED, HOWEVER NO ABNORMALITY WAS FOUND ON CORONARY ANGIOGRAPHY. PCPS (PERCUTANEOUS CARDIOPULMONARY SUPPORT) WAS USED, BUT THE PATIENT WAS NOT RECOVERED AND EXPIRED. IT WAS REPORTED THE CAUSE OF THE DECREASED HEART FUNCTION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807353 CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Death