BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II

    MDR report key: 3853987 · Received June 6, 2014

    Report

    Report Number
    2953200-2014-01143
    Event Type
    Death
    Date Received
    June 6, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (STENT GRAFT WAS IMPLANT IN A PATIENT WITH A PRE-OPERATIVELY RUPTURED ANEURYSM).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE STENT GRAFTS WERE IMPLANTED, AND A FINAL ANGIOGRAM SHOWED NO ENDOLEAK, AND THE PATIENT WAS STABLE. AFTER THE ACCESS VESSEL INCISIONS WERE CLOSED AND THE PATIENT WAS BEING PREPARED TO BE MOVED TO POST-OP, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP WITH NO CLINICAL REASON. THE PHYSICIAN INSERTED A RELIANT BALLOON, INFLATING IT TO KEEP THE PRESSURE FROM DROPPING. EACH TIME THE BALLOON WAS DEFLATED, THE PRESSURE DROPPED. THE PHYSICIAN OPENED THE PATIENT'S ABDOMEN, BUT WAS UNABLE TO FIND ANY ACTIVE BLEEDING IN THE ANEURYSM SAC OR BELLY. AT THIS POINT, THE PATIENT BEGAN TO OOZE BLOOD AND A REPAIR WAS ATTEMPTED. THE PATIENT CODED AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332327 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04119809

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Death