BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 8495645 · Received April 9, 2019

    Report

    Report Number
    2953200-2019-00461
    Event Type
    Injury
    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
    P100021
    Adverse Event
    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. 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: SERIOUS INJURY: RE-INTERVENTION RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290995 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention