BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 3872029 · Received June 13, 2014

    Report

    Report Number
    2953200-2014-01193
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    May 24, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT DIED FOUR DAYS AFTER IMPLANT. THE CAUSE OF DEATH WAS UNKNOWN FOR CERTAIN. ONE POSSIBLE CAUSE WAS ANEURYSM RUPTURE. THE PATIENT HAD AORTIC STENOSIS AND GI BLEEDING. AN AUTOPSY WAS REFUSED. THE PATIENT ALSO HAD HEART PROBLEMS AND THE PHYSICIAN HAD PLANNED TO DO A BYPASS IN THE FUTURE AND AN AVR.

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THERE WAS A SMALL ENDOLEAK AFTER THE DEVICE WAS IMPLANTED AND OBSERVED UPON FINAL ANGIO. THE ENODOLEAK IS LIKELY A TYPE I; HOWEVER, THE TYPE OF ENDOLEAK COULD NOT BE CONFIRMED AND IS UNKNOWN AT THIS TIME. THE PHYSICIAN WILL MONITOR THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349544 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04218230

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Death