BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 12908688 · Received December 1, 2021

    Report

    Report Number
    9612164-2021-04649
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    April 3, 2021
    Report Date
    December 1, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; TIME-TO-EVENT ANALYSIS OF THE IMPACT OF ENDOVASCULAR AORTIC ANEURYSM REPAIR ON CHRONIC RENAL DECLINE SUGIMOTO M, BANNO H, SATO T, IKEDA S, TSURUOKA T, KAWAI K, NIIMI K, KODAMA A, KOMORI K ANN VASC SURG 2021; 74: 165¿175 HTTPS://DOI.ORG/10.1016/J.AVSG.2021.02.031. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ENDURANT AND TALENT STENT GRAFTS AND NON MDT STENT GRAFTS WERE IMPLANTED IN 512 PATIENTS OVER A 10 YEAR PERIOD IN THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS . THE FOLLOWING INJURIES WERE REPORTED; CHRONIC KIDNEY INJURY REQUIRING DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806429 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention| H