BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5188354 · Received October 29, 2015

    Report

    Report Number
    2017233-2015-00737
    Event Type
    Death
    Date Received
    October 29, 2015
    Date of Event
    September 15, 2010
    Report Date
    October 1, 2015
    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

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

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM IN THE DISTAL AORTIC ARCH USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (TGT3415/8137735, TGT3415/8032687). PRIOR TO IMPLANTATION OF THE DEVICES, DEBRANCHING SURGERY WAS PERFORMED ON THE LEFT CAROTID ARTERY AND THE LEFT SUBCLAVIAN ARTERY. THE TWO GORE® DEVICES WERE IMPLANTED JUST BELOW THE INNOMINATE ARTERY. IT IS UNKNOWN WHICH DEVICE WAS IMPLANTED MOST PROXIMALLY. DURING THE PROCEDURE PARTIAL COVERAGE OF THE INNOMINATE ARTERY WAS DISCOVERED, AND A METAL STENT WAS PLACED IN THE INNOMINATE. THE PHYSICIAN IMPLANTED A METALLIC STENT IN THE INNOMINATE ARTERY AND RESTORED THE BLOOD FLOW. THE PROCEDURE WAS CONCLUDED WITH NO OTHER COMPLICATIONS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2015, THE PATIENT DEVELOPED A CEREBRAL ISCHEMIA. IT WAS IDENTIFIED THAT THE INNOMINATE ARTERY WAS NOW FULLY COVERED BY A TAG® DEVICE. IT IS UNKNOWN IF THERE WAS A MIGRATION OF THE DEVICES. ANOTHER METALLIC STENT WAS ADDED IN THE INNOMINATE ARTERY TO RESTORE THE BLOOD FLOW. DURING THIS PROCEDURE, THE PATIENT DEVELOPED A STROKE. IT WAS REPORTED THAT THE PATIENT'S PROXIMAL AORTIC NECK HAD SIGNIFICANT THROMBUS AND WAS SEVERELY CALCIFIED. ON (B)(6) 2010, THE PATIENT EXPIRED DUE TO THE STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719701 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8137735

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death (B)(6) 2010: TGT3415/8032687