BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 12664190 · Received October 20, 2021

    Report

    Report Number
    9612164-2021-04024
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Date of Event
    March 4, 2021
    Report Date
    October 20, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; AORTODUODENAL FISTULAS AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR AND OPEN AORTIC REPAIR OMRAN S, RAUDE B, BÜRGER M, KAPAHNKE S, CHRISTOPH CARSTENS J, HAIDAR H, KONIETSCHKE F, FRESE J P, GREINER A JOURNAL OF VASCULAR SURGERY 2021 74:711-9 HTTPS://DOI.ORG/10.1016/J.JVS.2021.02.027. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT II STENT GRAFTS AND NON MDT STENT GRAFTS WERE IMPLANTED IN PATIENTS IN EVAR PROCEDURES ON UNKNOWN DATES OVER A FIVE YEAR PERIOD. THE FOLLOWING MALFUNCTION WAS REPORTED; TYPE I ENDOLEAK THE FOLLOWING ADVERSE EVENTS WERE REPORTED AORTO-DUODENAL FISTULA , BLEEDING, FEVER , INFECTION, RENAL DYSFUNCTION, PNEUMONIA, INTERVENTIONS PATIENT DEATHS WERE REPORTED BUT THERE IS NO CAUSAL LINK THAT A ENDURANT STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565270 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 72 YR