BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 11601878 · Received April 1, 2021

    Report

    Report Number
    9612164-2021-01280
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    August 5, 2020
    Report Date
    April 1, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; SECONDARY INTERVENTIONS AND LONG-TERM FOLLOW-UP AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR GERAEDTS MC A MULAY S, VAHL A, WISSELINK W, KOELEMAY WJ M , BALM R ANNALS OFVASCULAR SURGERY 2021; 71: 381¿391 HTTPS://DOI.ORG/10.1016/J.AVSG.2020.07.042 IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT, TALENT AND NON MDT STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF INFRA- RENAL ABDOMINAL AORTIC ANEURYSMS. 16% OF THE PATIENT COHORT REQUIRED SECONDARY INTERVENTIONS. THE FOLLOWING MALFUNCTIONS WERE OBSERVED; TYPE I ENDOLEAK, TYPE II ENDOLEAK, TYPE III ENDOLEAK, TYPE V ENDOLEAK, MIGRATION, KINKING THE FOLLOWING ADVERSE EVENTS WERE OBSERVED; OCCLUSION, INFECTION, ANEURYSM EXPANSION, RUPTURE, PSEUDOANEURYSM, FISTULA AND RE-INTERVENTION PATIENT MORTALITY WAS 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
    499435 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR