BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX

    MDR report key: 8508126 · Received April 12, 2019

    Report

    Report Number
    2953200-2019-00493
    Event Type
    Death
    Date Received
    April 12, 2019
    Date of Event
    November 26, 2018
    Report Date
    April 12, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; SEX AS AN INDEPENDENT RISK FACTOR FOR LONG-TERM SURVIVAL AFTER ENDOVASCULAR ANEURYSM REPAIR. WILLIAM P. SHUTZE SR., RYAN SHUTZE, PAUL DHOT, MOSES FORGE, ALEJANDRO SALAZAR AND GERALD O. OGOLA. J VASC SURG 2019 69 (4). DOI: DOI.ORG/10.1016/J.JVS.2018.07.057. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ANUERX STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. THE FOLLOWING EVENTS WERE REPORTED: DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303201 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death