BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 12581909 · Received October 6, 2021

    Report

    Report Number
    9612164-2021-03834
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    December 21, 2020
    Report Date
    October 6, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; UTILITY OF NONCONTRAST MAGNETIC RESONANCE ANGIOGRAPHY FOR ANEURYSM FOLLOW-UP AND DETECTION OF ENDOLEAKS AFTER ENDOVASCULAR AORTIC REPAIR KAWADA H., GOSHIMA S., SAKURAI K., NODA Y., KAJITA K., TANAHASHI Y., KAWAI N., ISHIDA N., SHIMABUKURO K., DOI K., MATSUO M. KOREAN JOURNAL OF RADIOLOGY. 2021; 22(4):513-524 DOI: 10.3348/KJR.2020.0001. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT AND NON MDT STENT GRAFTS WERE IMPLANTED IN PATIENTS IN THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS ON UNKNOWN DATES. THE FOLLOWING MALFUNCTION WAS REPORTED; TYPE IA ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479826 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR