BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 10301551 · Received July 21, 2020

    Report

    Report Number
    9612164-2020-02672
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    May 14, 2020
    Report Date
    July 21, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; TYPE 2 ENDOLEAKS: COMMON AND HARD TO ERADICATE YET BENIGN? MENG LOY L, MING ER CHUA J, TEC CHONG T, TAR TOONG CHAO V, GILLAN IRANI F, DAMODHARAN K, LEONG S, CHANDRAMOHAN S, VENKATANARASIMHA N, PATEL A, HIONG TAY K. CARDIOVASCULAR INTERVENTIONAL RADIOLOGY (2020) 43:963¿970 HTTPS://DOI.ORG/10.1007/S00270-020-02497-3. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT STENT GRAFTS AND NON-MDT STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. THE FOLLOWING MALFUNCTIONS WERE OBSERVED; TYPE I ENDOLEAK, TYPE II ENDOLEAK, TYPE III ENDOLEAK THE FOLLOWING ADVERSE EVENTS WERE OBSERVED; ANEURYSM EXPANSION REQUIRING RE-INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768179 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR