BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 10385067 · Received August 10, 2020

    Report

    Report Number
    9612164-2020-02934
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    December 31, 2019
    Report Date
    August 10, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; DOUBLE REGION OF INTEREST TIMING BOLUS TECHNIQUE FOLLOWING ENDOVASCULAR AORTIC REPAIR: SHORT-TERM PROGNOSIS ANALYSIS TOMIZAWA N, ITO S, NAKAO T, ARAKAWA H, YAMAMOTO K, INOH S, NOJO T & NAKAMURA S. VASCULAR 2020, VOL. 28(3) 233¿240 10.1177/1708538119895403. 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 THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS AND 1 AORTIC OCCLUSION IN 40 PATIENTS. THE FOLLOWING MALFUNCTIONS WERE OBSERVED; ENDOLEAK THE FOLLOWING ADVERSE EVENTS WERE OBSERVED; INFECTION, RE-INTERVENTION ONE PATIENT DEATH WAS REPORTED BUT THERE WAS NO CAUSAL LINK THAT THE ENDURANT STENT GRAFT CAUSED OR CONTRIBUTED TO THIS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849525 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR