BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 10394763 · Received August 12, 2020

    Report

    Report Number
    9612164-2020-02956
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    February 5, 2020
    Report Date
    August 12, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ENDOVASCULAR TREATMENT FOR AORTIC ARCH PATHOLOGIES: CHIMNEY, ON-THE-TABLE FENESTRATION, AND IN-SITU FENESTRATION TECHNIQUES. CHANG S, FAN B, LUO M, LI Q, FANG K, LI M, LI X, HE H, WANG TUN, YANG C, XUE Y, GAO H & ZHAO J. JOURNAL OF THORACIC DISEASE 2020;12(4):1437-1448 HTTP://DX.DOI.ORG/10.21037/JTD.2020.03.10. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT STENT GRAFTS AND NON MDT STENT GRAFTS WERE IMPLANTED IN PATIENTS IN TEVAR PROCEDURES COMBINED WITH ADAPTED TECHNIQUES INCLUDING CHIMNEY AND ON-THE-TABLE FENESTRATION TECHNIQUES. THE FOLLOWING MALFUNCTIONS WERE OBSERVED; TYPE IA ENDOLEAK, TYPE II ENDOLEAK THE FOLLOWING ADVERSE EVENTS WERE OBSERVED; OCCLUSION, STROKE, ISCHEMIA, RENAL FAILURE, CARDIAC EVENTS, DISSECTION AND RE-INTERVENTION. PATIENT DEATHS WERE ALSO REPORTED BUT THERE WAS NO CAUSAL LINK THAT THE VALIANT STENT GRAFTS CAUSED OR CONTRIBUTED TO THESE DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861581 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR