BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 6019658 · Received October 12, 2016

    Report

    Report Number
    2953161-2016-00209
    Event Type
    Death
    Date Received
    October 12, 2016
    Date of Event
    May 8, 2014
    Report Date
    October 20, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK, EMBOLISM (MICRO AND MACRO) WITH TRANSIENT OR PERMANENT ISCHEMIA, AND DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A 60-MM DISSECTING THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT. AN ELEPHANT-TRUNK APPROACH WAS TAKEN TO IMPLANT A SURGICAL GRAFT DISTALLY TO THE AORTIC ARCH THAT HAD BEEN PREVIOUSLY REPLACED WITH A SURGICAL GRAFT. THE AORTIC EXTENDER COMPONENT WAS THEN DEPLOYED MOST DISTALLY IN THE DESCENDING THORACIC AORTA, FOLLOWED BY TWO GORE® TAG® THORACIC ENDOPROSTHESES BEING IMPLANTED IN THE SURGICAL GRAFT. AN INTRA-PROCEDURE IMAGING REVEALED A NEW DISSECTION (LOCATION UNKNOWN) AND A DISTAL TYPE I ENDOLEAK INVOLVING THE AORTIC EXTENDER COMPONENT, BUT THE PROCEDURE WAS CONCLUDED WITH A WAIT-AND-WATCH APPROACH BEING TAKEN TO THOSE EVENTS. ON (B)(6) 2011, A REINTERVENTION WAS PERFORMED TO TREAT THE DISTAL TYPE I ENDOLEAK AND THE AORTIC DISSECTION. THE PATIENT WAS IMPLANTED WITH TWO GORE® TAG® THORACIC ENDOPROSTHESES AND TWO AORTIC EXTENDER COMPONENTS PROXIMAL TO THE CELIAC ARTERY. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED OF THE HOSPITAL. IT WAS REVEALED THAT THE AORTIC DISSECTION AS WELL AS THE DISTAL TYPE I ENDOLEAK HAD RESOLVED AT THE TIME OF DISCHARGE. AORTIC DIAMETER WAS 63MM. ON (B)(6) 2011, IN A THREE-MONTH FOLLOW-UP STUDY, ANEURYSM DIAMETER WAS 63MM. IT WAS UNKNOWN IF ENDOLEAKS WERE PRESENT. LATER IN TWO MORE FOLLOW-UP STUDIES, ANEURYSM DIAMETER HAD REMAINED UNCHANGED, AND ENDOLEAKS WERE NOT REVEALED. ON (B)(6) 2012, IN TWO-YEAR FOLLOW-UP STUDY, THE ANEURYSM DIAMETER HAD EXPANDED TO 68MM DUE TO RETROGRADE PERFUSION FROM A RE-ENTRY TEAR IN THE ABDOMINAL AORTA. ON (B)(6) 2013, A REINTERVENTION WAS PERFORMED TO TREAT THE FALSE LUMEN EXPANSION. A DEBRANCHING PROCEDURE WAS PERFORMED TO MAINTAIN BLOOD FLOW TO THE BRANCH ARTERIES OF THE ABDOMINAL AORTA, AND TWO GORE® TAG® THORACIC ENDOPROSTHESES WERE IMPLANTED FOR DISTAL EXTENSION. ON (B)(6) 2014, IN THREE-YEAR FOLLOW-UP STUDY, ANEURYSM DIAMETER WAS 72MM. A TYPE II ENDOLEAK WAS REVEALED, BUT IT WAS MONITORED. ON (B)(6) 2015, IN FOUR-YEAR FOLLOW-UP STUDY, THE PERSISTENT TYPE II ENDOLEAK WAS REVEALED. ANEURYSM DIAMETER WAS 73MM. ON (B)(6) 2015, THE PATIENT UNDERWENT ANEURYSM EMBOLIZATION PROCEDURE USING AN N-BUTYL-2-CYANOACRYLATE (NBCA) TO TREAT THE PERSISTENT TYPE II ENDOLEAK. POST ANEURYSM EMBOLIZATION PROCEDURE, THE PATIENT SUFFERED FROM EMBOLISM IN ABDOMINAL ORGANS, RESULTING IN MULTIPLE ORGAN FAILURE. THE PATIENT EXPIRED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673931 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8375078

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| H| R (B)(4)