BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 13313618 · Received January 21, 2022

    Report

    Report Number
    9612164-2022-00288
    Event Type
    Malfunction
    Date Received
    January 21, 2022
    Date of Event
    August 17, 2021
    Report Date
    January 21, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ANALYSIS OF PROGNOSTIC FACTORS FOR POSTOPERATIVE COMPLICATIONS AND REINTERVENTIONS AFTER OPEN SURGICAL REPAIR AND ENDOVASCULAR ANEURYSM REPAIR IN PATIENTS WITH ABDOMINAL AORTIC ANEURYSM MORISAKI K, MATSUBARA Y, KUROSE S, YOSHINO S, YAMASHITA S, NAKAYAMA K, FURUYAMA T ANN VASC SURG 2021; 77: 172¿181 HTTPS://DOI.ORG/10.1016/J.AVSG.2021.05.018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ENDURANT AND NON MDT STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS ON UNKNOWN DATES. THE FOLLOWING MALFUNCTIONS WERE REPORTED; ENDOLEAK TYPE IA, IB, III THE FOLLOWING SERIOUS INJURIES WERE REPORTED; RUPTURE, ANEURYSM, DISSECTION, INFECTION, PULMONARY, CARDIAC, RENAL, 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
    610658 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male