BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT

    MDR report key: 8695331 · Received June 13, 2019

    Report

    Report Number
    9612164-2019-02319
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    November 28, 2018
    Report Date
    June 13, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; INFLUENCE OF TYPE OF FIXATION AND OTHER CHARACTERISTICS ON OUTCOME AFTER ENDOVASCULAR REPAIR OF RUPTURED ABDOMINAL AORTIC ANEURYSMS. ROBERTO SILINGARDI, GIOVANNI COPPI, FRANCESCA BENASSI, GIUSEPPE SAITTA, LUIGI MARCHESELLI, ANTONIO LAURICELLA, AND STEFANO GENNAI. ANN VASC SURG 2019 (57) HTTPS://DOI.ORG/10.1016/J.AVSG.2018.09.022. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT AND TALENT GRAFTS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF RUPTURED ABDOMINAL AORTIC ANEURYSMS. THE FOLLOWING EVENTS WERE REPORTED: MALFUNCTION - TYPE I ENDOLEAK INACCURATE DELIVERY (COVERAGE OF RENAL ARTERIES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489455 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR