BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 9218149 · Received October 22, 2019

    Report

    Report Number
    9612164-2019-04458
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 22, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; THE USE OF CLOSURE DEVICES FOR AORTIC STENT-GRAFT INSERTION: OUTCOMES FOLLOWING A PARADIGM SHIFT TO PERCUTANEOUS ACCESS IN A TERTIARY VASCULAR CENTER. DOI: 10.1177/1538574419858829 ALAN D. WHITE, CAN HAZAR, DAVID JAROSZ, PAUL WALKER, DAVID SHAW AND COSTA TINGERIDES. VASCULAR AND ENDOVASCULAR SURGERY 2019 VOL 54 ISSUE 7. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC AND NON-MEDTRONIC STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR THORACIC AND ABDOMINAL AORTIC REPAIRS. THE FOLLOWING EVENTS WERE REPORTED: MALFUNCTION: KINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015301 ENDURANT II STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1