BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ILIAC STENT GRAFT

    MDR report key: 4233409 · Received November 6, 2014

    Report

    Report Number
    2953200-2014-02349
    Event Type
    Death
    Date Received
    November 6, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 14, 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 II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.8 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS 20-25 DEGREE AORTIC NECK ANGULATION, MODERATE CALCIFICATION, AND THE DIAMETER OF THE AORTIC NECK BELOW THE RENAL ARTERIES WAS 24 MM. THE STENT GRAFTS WERE IMPLANTED. TWO DAYS POST INDEX PROCEDURE THE PATIENT WAS DEHYDRATED. IT WAS REPORTED THAT THE PATIENT HAD CARDIAC COMPLICATIONS TWO YEARS POST INDEX PROCEDURE AND EXPIRED, HOWEVER THE INVESTIGATOR DID NOT INDICATED IF THE DEATH WAS RELATED TO THE DEVICE OR PROCEDURE. CAUSE OF DEATH UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713432 ENDURANT ILIAC STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01033047

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Death