BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5066884 · Received September 10, 2015

    Report

    Report Number
    2017233-2015-00592
    Event Type
    Death
    Date Received
    September 10, 2015
    Date of Event
    August 13, 2015
    Report Date
    August 17, 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

    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) 2014, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A DISTAL AORTIC ARCH ANEURYSM (WITH ITS ANEURYSM DIAMETER WAS 55MM) USING TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES ((B)(4)). PRIOR TO STENT GRAFTS BEING IMPLANTED, AN AXILLO-AXILLARY BYPASS PROCEDURE WAS PERFORMED TO MAINTAIN BLOOD FLOW TO THE BRANCH ARTERIES OF THE AORTIC ARCH. TWO STENT GRAFTS WERE THEN DEPLOYED JUST BELOW THE LEFT COMMON CAROTID ARTERY, AND THE PROCEDURE WAS CONCLUDED WITHOUT ENDOLEAKS PRESENT. ON (B)(6) 2015, IN SIX-MONTH FOLLOW-UP STUDY, ENDOLEAKS HAD NOT BEEN REVEALED. ANEURYSM DIAMETER HAD SHRUNK TO 50MM. ON (B)(6) 2015, THE PATIENT WAS EMERGENTLY PRESENTED TO THE HOSPITAL. A LARGE BLEEDING WAS REVEALED INTO THE LEFT THORACIC CAVITY AND THE PATIENT WAS DIAGNOSED WITH ANEURYSM RUPTURE. HOWEVER, THERE WAS NO ROOM LEFT FOR RESUSCITATION TO BE PERFORMED, AND THE PATIENT EXPIRED ON THE SAME DAY. IT WAS REPORTED THAT THE PATIENT SUDDENLY GOT IN CARDIOPULMONARY ARREST IN HER HOUSE, AND SHE WAS EMERGENTLY PRESENTED TO THE HOSPITAL. WHEN THE PATIENT WAS PRESENTED TO THE HOSPITAL, SHE HAD ALREADY BEEN IN CARDIOPULMONARY ARREST, AND ANY RESUSCITATION WAS NOT TAKEN. IT WAS ALSO REPORTED THAT AN AUTOPSY WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT WANT IT. PRE-IMPLANTATION EXAMS SHOWED THAT THERE WAS CALCIUM ONLY IN A VERY LIMITED AREA AND THERE WAS NO SPECIFIC ABNORMALITY TO THE PATIENT'S VESSEL. ADDITIONALLY, THERE WAS NO ANEURYSM FOUND EXCEPT THE THORACIC AORTIC ANEURYSM THAT WAS TREATED BY ENDOVASCULAR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598159 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 13107150

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death (B)(4)