BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1622461 · Received March 1, 2010

    Report

    Report Number
    2017233-2010-00097
    Event Type
    Death
    Date Received
    March 1, 2010
    Date of Event
    February 11, 2010
    Report Date
    February 26, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE HAS BEEN CONDUCTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES RELATED TO THIS EVENT INCLUDE: (B) (4). THE INSTRUCTIONS FOR USE (IFU) FOR GORE TAG THORACIC ENDOPROSTHESIS STATE: INTENDED USE: THE GORE TAG THORACIC ENDOPROSTHESIS IS INDICATED FOR ENDOVASCULAR REPAIR OF THE DESCENDING THORACIC AORTA. UNDER WARNINGS, IT STATES: DO NOT USE GORE TAG THORACIC ENDOPROSTHESIS IF SIGNIFICANT THROMBUS IS PRESENT IN THE PROXIMAL OR DISTAL AORTIC IMPLANTATION SITES.

    Description of Event or Problem · 1

    ON (B) (6) 2010, THE PATIENT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS FOR TREATMENT OF A THORACIC AORTIC ARCH ANEURYSM. THE ANEURYSM MEASURED 50MM AND WAS LOCATED AT THE LEVEL OF THE LEFT SUBCLAVIAN ARTERY (LSA). A DACRON GRAFT WAS USED AS A CONDUIT TO BYPASS THE ASCENDING AORTA. THERE WAS SIGNIFICANT THROMBUS PRESENT ALL ALONG THE AORTIC ARCH AND THE DESCENDING AORTA. DIFFICULTIES WERE EXPERIENCED WITH C-ARM ORIENTATION, THAT HADN'T ALLOWED GOOD VISUALIZATION OF THE DACRON GRAFT AND THE PROXIMAL LANDING ZONE FOR THE TAG THORACIC ENDOPROSTHESIS. WHILE MAKING A CONTROL ANGIOGRAPHY OF THE DACRON GRAFT AND THE TAG THORACIC ENDOPROSTHESIS PATENT, THE PHYSICIAN WAS MADE AWARE THAT THE PATIENT HAD NO ARTERIAL PRESSURE. THE AORTA RUPTURED MINUTES LATER AND THE PATIENT WAS CONVERTED TO OPEN. THE PHYSICIAN BELIEVES THE DEVICE MOVED DURING DEPLOYMENT. UPON OPENING THE PATIENT, THE PHYSICIAN SAW THE FLARES OF THE TAG THORACIC ENDOPROSTHESIS AT THE LEVEL OF THE AORTIC VALVE AND THE DACRON GRAFT ANASTOMOSIS WAS CLOSED TO THE HEART. THE PATIENT EXPERIENCED A CARDIAC STROKE AND EXPIRED. THE DEVICE REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES, INC WLG326 7357019

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death| H| L| O