BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 8221384 · Received January 7, 2019

    Report

    Report Number
    2953200-2019-00020
    Event Type
    Injury
    Date Received
    January 7, 2019
    Date of Event
    June 15, 2018
    Report Date
    January 7, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; LONG-TERM OUTCOMES OF STANDARD ENDOVASCULAR ANEURYSM REPAIR IN PATIENTS WITH SEVERE NECK ANGULATION. NELSON F. G. OLIVEIRA, FREDERICO BASTOS GONÇALVES, SANNE E. HOEKS, MARIE JOSEE VAN RIJN, KLAAS ULTEE, JOSÉ PEDRO PINTO, SANDER TEN RAA, JOOST A. VAN HERWAARDEN, JEAN-PAUL P. M. DE VRIES <(>&<)> J. M. VERHAG. J VASC SURG 2018 (68) ISSUE 6 HTTPS://DOI.ORG/10.1016/J.JVS.2018.03.427. EXACT EVENT DATE UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED INTO PATIENTS FOR ENDOVASCULAR ANEURYSM REPAIR BETWEEN 2008 AND 2009. IT WAS NOTED BY THE JOURNAL ARTICLES AUTHORS THAT THEY REGARD PATIENT FACTORS RATHER THAN DEVICE RELATED FACTORS AS BEING DETERMINANT OF A HIGHER RISK OF SEAL COMPLICATIONS ON THE LONGER-TERM. THE FOLLOWING EVENTS WERE REPORTED: SERIOUS INJURY: RUPTURE, ANEURYSM ENLARGEMENT, INFECTION, OCCLUSION, SECONDARY INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14763 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention