BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX

    MDR report key: 8495560 · Received April 9, 2019

    Report

    Report Number
    2953200-2019-00459
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Date of Event
    January 1, 2019
    Report Date
    April 9, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; RESCUE OF PROXIMAL FAILURE OF ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR WITH STANDARD AND FENESTRATED GRAFTS. PABLO MARQUES DE MARINO, RAFAEL D. MALGOR, ERIC L. VERHOEVEN AND ATHANASIOS KATSARGYRIS J CARDIO VASC SURG 2019 60 (2) DOI: 10.23736/S0021-9509.19.10872-5. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. THE PATIENTS UNDERWENT ELECTIVE IMPLANTATION OF A STANDARD OR FENESTRATED GRAFT FOR PROXIMAL FAILURE OF THE PREVIOUS EVAR. THE FOLLOWING EVENTS WERE REPORTED: MALFUNCTION: TYPE IA ENDOLEAK INACCURATE DELIVERY MIGRATION TYPE IIIB DISLODGED TYPE IB ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289443 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR