BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 7172165 · Received January 8, 2018

    Report

    Report Number
    2953200-2018-00030
    Event Type
    Death
    Date Received
    January 8, 2018
    Date of Event
    May 31, 2017
    Report Date
    January 8, 2018
    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 JOURNAL ARTICLE ENTITLED; THE EFFECT OF ENDOGRAFT DEVICE ON PATIENT OUTCOMES IN ENDOVASCULAR REPAIR OF RUPTURED ABDOMINAL AORTIC ANEURYSMS. OTTAWA HOSPITAL CIVIL CAMPUS, 1053 CARLING AVENUE, ROOM A280, OTTAWA, ON KIY 4E9, CANADA VINAY KANSAL, SUDHIR NAGPAL AND PRASAD JETTY. (INTERNATIONAL SOCIETY FOR VASCULAR SURGERY 2017;25(6):657-665). DATE OF DEATH: UNKNOWN. 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 PATIENTS FOR THE ENDOVASCULAR TREATMENT OF RUPTURED ABDOMINAL ANEURYSMS. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14618 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death