BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-CV-SR-ENDUR-II

    MDR report key: 8073332 · Received November 15, 2018

    Report

    Report Number
    2953200-2018-01584
    Event Type
    Injury
    Date Received
    November 15, 2018
    Date of Event
    April 26, 2018
    Report Date
    November 15, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; PROCEDURAL AND PERIOPERATIVE RESULTS IN PATIENTS TREATED WITH FENESTRATED ENDOVASCULAR ANEURYSM REPAIR PLANNED BY AUTOMATED SOFTWARE IN A PHYSICIAN-SPONSORED INVESTIGATIONAL DEVICE EXEMPTION TRIAL OF PHYSICIAN-MODIFIED ENDOGRAFTS. BENJAMIN W. STARNES, BILLI TATUM, AND NITEN SINGH, SEATTLE, WASH J VASC SURG 2018 (68) DOI.ORG/10.1016/J.JVS.2018.02.045, (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT II STENT GRAFT SYSTEMS WERE IMPLANTED INTO PATIENTS FOR FENESTRATED ENDOVASCULAR ANEURYSM REPAIR OF JUXTARENAL ABDOMINAL AORTIC ANEURYSM'S (AAA). THE FOLLOWING EVENTS WERE REPORTED: SERIOUS INJURY: STROKE MI RENAL FAILURE RESPIRATORY FAILURE PARALYSIS BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913875 UNK-CV-SR-ENDUR-II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other