BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 12712065 · Received October 28, 2021

    Report

    Report Number
    9612164-2021-04116
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    July 17, 2020
    Report Date
    October 28, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    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; IN SITU LASER STENT GRAFT FENESTRATION OF THE LEFT SUBCLAVIAN ARTERY DURING THORACIC ENDOVASCULAR REPAIR OF TYPE B AORTIC DISSECTION WITH LIMITED PROXIMAL LANDING ZONES: 5-YEAR OUTCOMES ZHAO Z, QIN J, YIN M, LIU G, LIU X, YE K, WANG R, SHI H, LI W, JIANG M, LU X J VASC INTERV RADIOL 2020; 31:1321¿1327 HTTPS://DOI.ORG/10.1016/J.JVIR.2020.02.025. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT AND NON MDT STENT GRAFTS WERE IMPLANTED IN PATIENTS IN THE ENDOVASCULAR TREATMENT OF TYPE B AORTIC DISSECTIONS. ALL STENT GRAFTS RECEIVED IN SITU LASER FENESTRATION. THE FOLLOWING MALFUNCTIONS WERE OBSERVED; TYPE I ENDOLEAK, ALL CONFIRMED TO HAVE RESOLVED AT FOLLOW-UP THE FOLLOWING ADVERSE EVENTS WERE OBSERVED; PSEUDOANEURYSM, OCCLUSION REQUIRING INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1608859 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R