BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT BIFURCATED STENT GRAFT

    MDR report key: 5015079 · Received August 19, 2015

    Report

    Report Number
    2953200-2015-01356
    Event Type
    Death
    Date Received
    August 19, 2015
    Date of Event
    March 15, 2015
    Report Date
    July 27, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO EXACERBATION OF RENAL INSUFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547029 ENDURANT BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ENBF2816C170EE

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Death