BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 12834713 · Received November 18, 2021

    Report

    Report Number
    9612164-2021-04472
    Event Type
    Malfunction
    Date Received
    November 18, 2021
    Date of Event
    February 3, 2021
    Report Date
    November 18, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; COMPARISON OF OUTCOMES FOLLOWING EVAR BASED ON ANEURYSM DIAMETER AND VOLUME AND THEIR POSTOPERATIVE VARIATIONS MONTELIONE ET AL, ANN VASC SURG VOLUME 74, P183-193, JULY 01, 2021 HTTPS://DOI.ORG/10.1016/J.AVSG.2020.12.048. EXACT DATE OF IMPLANT UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ENDURANT AND ENDURANT II STENT GRAFT SYSTEMS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: TYPE IA AND TYPE IB ENDOLEAKS. THE CAUSE OF THE ENDOLEAKS ARE UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736341 ENDURANT II STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDUR-II

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male