BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT AUI STENT GRAFT

    MDR report key: 5015111 · Received August 19, 2015

    Report

    Report Number
    2953200-2015-01363
    Event Type
    Death
    Date Received
    August 19, 2015
    Date of Event
    March 28, 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; CAUSE OF DEATH WAS BRAIN STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547023 ENDURANT AUI STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ENUF3214C105EE

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Death