BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II

    MDR report key: 3930272 · Received July 11, 2014

    Report

    Report Number
    2953200-2014-01382
    Event Type
    Death
    Date Received
    July 11, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.5CM ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WAS NOT REPORTED. APPROXIMATELY SEVEN DAYS POST EVAR REPAIR IT WAS REPORTED THAT THE PATIENT RUPTURED AND THE PATIENT EXPIRED. THE CAUSE OF THE RUPTURE IS UNKNOWN; HOWEVER, THE RUPTURE WAS ABOVE THE STENT GRAFT. THE CAUSE OF DEATH WAS DUE TO THE RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406106 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04262524

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Death