BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-CV-SR-ENDURANT

    MDR report key: 8830264 · Received July 26, 2019

    Report

    Report Number
    9612164-2019-03062
    Event Type
    Injury
    Date Received
    July 26, 2019
    Date of Event
    December 7, 2017
    Report Date
    July 26, 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 FROM THE JOURNAL ARTICLE ENTITLED; EDITOR'S CHOICE ¿ LATE OPEN SURGICAL CONVERSION AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR VINAY KANSAL, SUDHIR NAGPAL AND PRASAD JETTY EUR J VASC ENDOVASC SURG 2018 55 (2) HTTPS://DOI.ORG/10.1016/J.EJVS.2017.10.011. 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 ENDOVASCULAR AORTIC ANEURYSM REPAIR. THE FOLLOWING EVENTS WERE REPORTED: SERIOUS INJURY- ANEURYSM ENLARGEMENT, RUPTURE, INFECTED GRAFT, CONGESTIVE HEART FAILURE, OPEN SURGICAL CONVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624449 UNK-CV-SR-ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention