BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 13504997 · Received February 10, 2022

    Report

    Report Number
    9612164-2022-00555
    Event Type
    Injury
    Date Received
    February 10, 2022
    Date of Event
    August 3, 2021
    Report Date
    February 10, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; AN INTERNATIONAL, MULTICENTER RETROSPECTIVE OBSERVATIONAL STUDY TO ASSESS TECHNICAL SUCCESS AND CLINICAL OUTCOMES OF PATIENTS TREATED WITH AN ENDOVASCULAR ANEURYSM SEALING DEVICE FOR TYPE III ENDOLEAK ZOETHOUT AC, KETTING S, ZEEBREGTS CJ, ET AL JOURNAL OF ENDOVASCULAR THERAPY. 2022;29(1):57-65. DOI:10.1177/15266028211031933. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ENDURANT, TALENT AND NON MDT STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS ON UNKNOWN DATES. THE FOLLOWING MALFUNCTIONS WERE REPORTED; TYPE IA ENDOLEAK, TYPE IIIA ENDOLEAK, TYPE IIIB ENDOLEAK THE FOLLOWING ADVERSE EVENTS WERE REPORTED; CLAUDICATION, INFECTION, WOUND DEHISCENCE, ANEURYSM ENLARGEMENT, MYOCARDIAL INFRACTION , RE-INTERVENTION PATIENT DEATHS WERE REPORTED BUT THERE IS NO CAUSAL LINK THAT A MDT STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296313 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention