BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT BIFURCATED STENT GRAFT

    MDR report key: 6062476 · Received October 27, 2016

    Report

    Report Number
    2953200-2016-01871
    Event Type
    Death
    Date Received
    October 27, 2016
    Date of Event
    April 5, 2016
    Report Date
    October 20, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ENLW1620C120EE, SN (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.2 CM ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT THERE WAS MODERATE ILIAC TORTUOSITY ON BOTH SIDES. THERE WAS ALSO 30 CIRCUMFERENTIAL MURAL THROMBUS/CALCIFICATION AT THE PROXIMAL NECK. IT WAS REPORTED THAT THE PATIENT DIED. PER THE INVESTIGATOR THE CAUSE OF DEATH IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710948 ENDURANT BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ENBF2516C170EE

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death