BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ILIAC STENT GRAFT

    MDR report key: 4955125 · Received July 30, 2015

    Report

    Report Number
    2953200-2015-01192
    Event Type
    Death
    Date Received
    July 30, 2015
    Date of Event
    April 12, 2015
    Report Date
    July 12, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 A 57 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. IT WAS NOTED THAT THE PATIENT HAD BEEN HOSPITALIZED THE MONTH PRIOR WITH ACUTE EXACERBATION OF COPD. THE INVESTIGATOR ASSESSED THE DEATH AS NOT PROCEDURE RELATED. DEVICE RELATION IS UNKNOWN, WAS NOT PROVIDED BY THE INVESTIGATOR. NO AUTOPSY WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497289 ENDURANT ILIAC STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ENLW1616C120EE

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Death