BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II

    MDR report key: 3981840 · Received August 5, 2014

    Report

    Report Number
    2953200-2014-01521
    Event Type
    Death
    Date Received
    August 5, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. THE CASE WAS UNEVENTFUL AND THE PATIENT WAS DISCHARGED AND WENT HOME ONE DAY POST IMPLANT. IT WAS REPORTED THAT THE PATIENT EXPIRED TWO DAYS POST IMPLANT. THE PHYSICIAN INDICATED THERE WAS THROMBUS IN THE THORACIC AORTA ABOVE THE ANATOMY WHERE THERE STENT GRAFT WAS PLACED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458394 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04651183

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Death