BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 10598776 · Received September 29, 2020

    Report

    Report Number
    9612164-2020-03668
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    December 18, 2019
    Report Date
    September 29, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    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; ANEURYSM SAC THROMBUS VOLUME PREDICTS ANEURYSM EXPANSION WITH TYPE II ENDOLEAK AFTER ENDOVASCULAR ANEURYSM REPAIR FUJII T, BANNO H, KODAMA A, SUGIMOTO M, AKITA N, TSURUOKA T, SAKAKIBARA M, KOMORI K. ANNALS OF VASCULAR SURGERY 2020; 66: 85E94 HTTPS://DOI.ORG/10.1016/J.AVSG.2019.11.045. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT <(>&<)> TALENT STENT GRAFTS AND NON MDT STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. THE FOLLOWING MALFUNCTIONS WERE OBSERVED; TYPE IA ENDOLEAK, TYPE IB ENDOLEAK, TYPE II ENDOLEAK, TYPE III ENDOLEAK, MIGRATION, ACCESS PROBLEMS THE FOLLOWING ADVERSE EVENTS WERE OBSERVED; SAC EXPANSION, RUPTURE, RE -INTERVENTION A PATIENT DEATH WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A MDT STENT GRAFT CAUSED OR CONTRIBUTED TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064152 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention