BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK-CV-SR-ENDURANT

    MDR report key: 8225743 · Received January 8, 2019

    Report

    Report Number
    2953200-2019-00040
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Date of Event
    October 23, 2017
    Report Date
    January 8, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; CHARACTERIZATION AND OUTCOMES OF REINTERVENTIONS IN FOOD AND DRUG ADMINISTRATION-APPROVED VERSUS TRIAL ENDOVASCULAR ANEURYSM REPAIR DEVICES. ALEXANDER S. FAIRMAN, MD, GRACE J. WANG, MD, BENJAMIN M. JACKSON, MD, PAUL J. FOLEY, MD, SCOTT M. DAMRAUER, MD, VENKAT KALAPATAPU, MD, MICHAEL A. GOLDEN, MD, AND RONALD M. FAIRMAN, MD J VASC SURG 2018 (67) ISSUE 4 HTTPS://DOI.ORG/10.1016/J.JVS.2017.08.058. 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 FOR ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. THE AVERAGE ANEURYSM SIZE WAS 59MM. THE FOLLOWING EVENTS WERE REPORTED: MALFUNCTION: TYPE I ENDOLEAK TYPE III ENDOLEAK LIMB KINK ENDOTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20441 UNK-CV-SR-ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR