BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 3962004 · Received July 28, 2014

    Report

    Report Number
    2953200-2014-01473
    Event Type
    Death
    Date Received
    July 28, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 6, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT CODED AND EXPIRED FROM A SUSPECTED HEART ATTACK. THERE WERE NO ISSUES DURING THE PROCEDURE. NO AUTOPSY REPORT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437766 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04256548

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death