BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4066888 · Received September 8, 2014

    Report

    Report Number
    2017233-2014-00461
    Event Type
    Injury
    Date Received
    September 8, 2014
    Date of Event
    January 27, 2010
    Report Date
    September 7, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2009, A REPLACEMENT OF AN ASCENDING AORTA AND DEBRANCHING SURGERY OF THE BRACHIOCEPHALIC, THE LEFT COMMON CAROTID, AND THE LEFT SUBCLAVIAN ARTERIES WERE PERFORMED. ON (B)(6) 2010, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING GORE® TAG® THORACIC ENDOPROSTHESES (TG3415/7306625, TG3420/05626826) TO REPAIR A DISSECTING ANEURYSM OF THE THORACIC AORTA WITH DIAMETER OF 76MM. AS KTI SHEATH (COOK) WAS ADVANCED AT THE HIGHLY TORTUOUS DESCENDING THORACIC AORTA, THE PATIENT'S BLOOD PRESSURE DRASTICALLY DROPPED. AS AN ANGIOGRAPHY REVEALED ANEURYSM RUPTURE, THE PHYSICIAN ATTEMPTED TO REPAIR IT BY IMPLANTING THE DEVICES. HOWEVER THIS WAS NOT SUCCESSFUL AND THEREFORE THE PROCEDURE WAS CONVERTED TO OPEN SURGERY, USING PERCUTANEOUS CARDIOPULMONARY SUPPORT DEVICE (PCPS). HEMOSTASIS WAS NOT POSSIBLE AND THEN DURING THE PROCEDURE THE PATIENT EXPIRED DUE TO BLOOD LOSS (22,500ML) FROM THE RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547561 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7306625

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| L