BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 8771510 · Received July 9, 2019

    Report

    Report Number
    9612164-2019-02779
    Event Type
    Death
    Date Received
    July 9, 2019
    Date of Event
    September 15, 2017
    Report Date
    July 9, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE ABSTRACT ENTITLED "DEVICE-SPECIFIC VARIABILITY IN ANEURYSM SAC REGRESSION FOLLOWING ENDOVASCULAR ANEURYSM REPAIR BASED ON A COMPREHENSIVE REGISTRY OF PATIENTS IN EASTERN ONTARIO" PRESENTED AT THE CANADIAN SOCIETY FOR VASCULAR SURGERY'S 39TH ANNUAL MEETING. PRASAD JETTY, DON HUSEREAU, VINAY KANSAL, TINGHUA ZHANG, SUDHIR NAGPAL, OTTAWA, CANADA. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED; 30 DAY MORTALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565539 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death