BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 7463621 · Received April 26, 2018

    Report

    Report Number
    2953200-2018-00605
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    March 13, 2018
    Report Date
    April 26, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; OUTCOMES OF USING ENDOVASCULAR ANEURYSM REPAIR WITH ACTIVE FIXATION IN COMPLEX ANEURYSM MORPHOLOGY RAMI O. TADROS, MD, ALEX SHER, BS, MARTIN KANG, BS, AGELIKI VOUYOUKA, MD, WINDSOR TING, MD, DANIEL HAN, MD, MICHAEL MARIN, MD, AND PETER FARIES, SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER INC. HTTPS://DOI.ORG/10.1016/J.JVS.2017.12.039. 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 IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: MALFUNCTION: TYPE IA, IB AND II ENDOLEAKS, OCCLUSION OF STENT GRAFT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308301 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR