BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT BIFURCATED STENT GRAFT

    MDR report key: 4965933 · Received August 4, 2015

    Report

    Report Number
    2953200-2015-01224
    Event Type
    Death
    Date Received
    August 4, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 13, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY TO THE ER WITH SEVERE ABDOMINAL PAIN. A CONTRAST CT WAS PERFORMED AND AN INFRARENAL RUPTURED ANEURYSM WAS DISCOVERED. THE TYPE I ENDOLEAK WAS NOT DISCOVERED ON ROUTINE FOLLOW UP ULTRASOUND RECENTLY PERFORMED. THE CAUSE OF THE TYPE I ENDOLEAK LEADING TO RUPTURE WAS DUE TO CONTINUED DISEASE PROGRESSION, PER THE PHYSICIAN. THE DECISION WAS MADE BY THE PHYSICIAN TO REPAIR THE ENDOLEAK WITH AN ENDURANT PROXIMAL EXTENSION CUFF. DURING REPAIR THE PATIENT BECAME HYPOTENSIVE. A RELIANT BALLOON WAS USED TO RESTORE BLOOD PRESSURE AND THE 36X36X70 ENDURANT AORTIC CUFF WAS IMPLANTED. ADEQUATE BLOOD PRESSURE WAS NEVER RESTORED AND PATIENT WAS PRONOUNCED DECEASED INTRA OP. PER THE PHYSICIAN THE PATIENT¿S DEATH WAS DUE TO HYPOTENSION DURING REVISION OF THE ORIGINAL STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506596 ENDURANT BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ENBF3216C166E

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Death| R