BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 12590150 · Received October 7, 2021

    Report

    Report Number
    9612164-2021-03857
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    December 29, 2020
    Report Date
    October 7, 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; TEN-YEAR CLINICAL CHARACTERISTICS AND EARLY OUTCOMES OF TYPE B AORTIC DISSECTION PATIENTS WITH THORACIC ENDOVASCULAR AORTIC REPAIR HUANG L., KAN Y., ZHU T., CHEN B., XU X., DONG Z., GUO D., SI Y., FU W. VASCULAR AND ENDOVASCULAR SURGERY. 2021; 55(4):332-341. DOI: 10.1177/1538574420983652. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT, TALENT AND NON MDT STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF AORTIC DISSECTIONS ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED; RTAD, KIDNEY INJURY, PARAPLEGIA, STROKE, ISCHEMIA, RUPTURE, FISTULA, BLEEDING 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
    1490193 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R