BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 3900371 · Received June 27, 2014

    Report

    Report Number
    2953200-2014-01303
    Event Type
    Death
    Date Received
    June 27, 2014
    Date of Event
    May 30, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT LIMB WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 46MM IN DIAMETER AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO AN UNKNOWN CAUSE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS NOTED FROM THE FACILITY AND DEATH CERTIFICATE LIST GASTROINTESTINAL BLEEDING AS THE CAUSE OF DEATH. THE INVESTIGATOR ASSESSED THE EVENT AS NOT DEVICE OR PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377069 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00292082

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Death