BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 12679445 · Received October 22, 2021

    Report

    Report Number
    9612164-2021-04049
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    April 3, 2021
    Report Date
    October 22, 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; LIMB OCCLUSION RATE AFTER EVAR WITH INDIVIDUALIZED GRAFT LIMB SELECTION AND A LIBERAL PROTOCOL OF PRIMARY RELINING MARQUES DE MARINO P, IBRAHEEM A, GAFUR N, MUFTY H, SCHUBERT N, VERHOEVEN E, KATSARGYRIS A ANNALS OF VASCULAR SURGERY 2021; 75: 445¿454 HTTPS://DOI.ORG/10.1016/J.AVSG.2021.02.046. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT AND NON MDT STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS ON UNKNOWN DATES. 5% OF THE PATIENT COHORT RECEIVED ENDURANT STENT GRAFTS. THE FOLLOWING MALFUNCTION WAS REPORTED; TYPE I ENDOLEAK THE FOLLOWING ADVERSE EVENTS WERE REPORTED; WOULD DEHISCENCE/INFECTION, ISCHEMIA, OCCLUSION, RENAL DYSFUNCTION, CLAUDICATION, PNEUMONIA, HEART INSUFFICIENCY 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
    1583482 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR