BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 6060766 · Received October 27, 2016

    Report

    Report Number
    2017233-2016-00829
    Event Type
    Death
    Date Received
    October 27, 2016
    Date of Event
    August 5, 2016
    Report Date
    December 22, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM OF THE WHOLE DESCENDING AORTA AND WAS IMPLANTED WITH THREE CONFORMABLE GORE(TM) TAG(TM) THORACIC ENDOPROSTHESES. REPORTEDLY, THE PATIENT PRESENTED WITH A GREAT AMOUNT OF THROMBUS ON THE WALLS OF THE AORTIC ARCH, THE ASCENDING AND THE ABDOMINAL AORTA. IT WAS ENVISAGED TO POSITION 3 GORE(TM) TAG(TM) THORACIC ENDOPROSTHESES, STARTING FROM THE AREA BELOW THE ISTHMUS DOWN TO THE SUPERIOR MESENTERIC ARTERY (SMA). AFTER HAVING PLACED THE FIRST TWO TGE404015 AND TGE404020 ENDOPROSTHESES IN THE INTENDED LOCATION, INTRA-OPERATIVE IMAGING REVEALED THAT THE AORTA BELOW THE TWO STENT GRAFTS WAS FULL OF FLOATING THROMBUS. IT WAS ALSO NOTED THAT OVER A SHORT TIME SPAN, THE INCREASING AMOUNT OF THROMBUS STARTED TO OCCLUDE THE AORTA AND WERE ALSO FILLING THE ALREADY IMPLANTED THORACIC COMPONENTS. IN AN ATTEMPT TO HELP SQUEEZE THE FLOATING THROMBUS TOWARDS THE AORTIC WALL, THE PHYSICIAN DECIDED TO PLACE THE THIRD TGE454520 ENDOPROSTHESIS, LEADING TO AN IMPROVED SITUATION IN THE DISTAL AORTA. ALTHOUGH THE BLOOD FLOW SEEMED BETTER AND THE PATIENT WAS STABLE, THE FINAL COMPUTED TOMOGRAPHY ANGIOGRAM SHOWED A SUBSTANTIAL AMOUNT OF THROMBUS ALSO INSIDE THE IMPLANTED ENDOPROSTHESES. ON (B)(6) 2016, A REINTERVENTION WAS PERFORMED IN AN ATTEMPT TO REMOVE SOME THROMBUS FROM THE ACCESS VESSELS WITH THE PATIENT SUBSEQUENTLY APPEARING TO BE RECOVERING AND FEELING BETTER. FOLLOWING THE REINTERVENTION, THE PATIENT EXPIRED THE NEXT DAY, (B)(6) 2016, DUE TO CARDIAC ARREST.

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOTS INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712943 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 15150392

    Patients

    Seq Age Sex Outcome Treatment
    0 Death| H
    1 68 YR Death| H