BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK-CV-SR-ENDURANT

    MDR report key: 7808280 · Received August 23, 2018

    Report

    Report Number
    2953200-2018-01195
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    May 14, 2018
    Report Date
    August 23, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; IMPACT OF STENT-GRAFT OVERSIZING ON GUTTER AREAS AFTER CHIMNEY GRAFT REPAIR FOR COMPLEX ABDOMINAL AORTIC ANEURYSMS. ROMAIN DE BLIC, FREDERIC COCHENNEC, FARIS ALOMRAN, HICHAM KOBEITER, ERIC ALLAIRE, PASCAL DESGRANGES AND JEAN-PIERRE BECQUEMIN ANN VASC SURG 2018; 51: 200¿206 DOI.ORG/10.1016/J.AVSG.2018.02.040. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT STENT GRAFTS WERE IMPLANTED INTO PATIENTS IN CONJUNCTION WITH CHIMNEY GRAFTS FOR THE ENDOVASCULAR TREATMENT OF COMPLEX ABDOMINAL AORTIC ANEURYSMS, AND TYPE I ENDOLEAKS AFTER STANDARD EVAR. THE FOLLOWING EVENTS WERE OBSERVED: MALFUNCTION: TYPE IA ENDOLEAK STENT GRAFT KINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649818 UNK-CV-SR-ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1