BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 10745940 · Received October 28, 2020

    Report

    Report Number
    9612164-2020-04099
    Event Type
    Injury
    Date Received
    October 28, 2020
    Date of Event
    February 20, 2020
    Report Date
    October 28, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    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; PREOPERATIVE DISTAL AORTIC DIAMETER IS A SIGNIFICANT PREDICTOR OF LATE AORTA-RELATED EVENTS AFTER ENDOVASCULAR REPAIR FOR CHRONIC TYPE B AORTIC DISSECTION OISHI Y, YAMASHITA Y, KIMURA S, SONODA H, MATSUYAMA S, USHIJIMA T, FUJITA S, TATEWAKI H, TANOUE Y, SHIOSE A. GENERAL THORACIC AND CARDIOVASCULAR SURGERY (2020) 68:1086¿1093 HTTPS://DOI.ORG/10.1007/S11748-020-01318-1. 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 THE ENDOVASCULAR TREATMENT OF FOR CHRONIC TYPE B AORTIC DISSECTION <(>&<)> THORACIC AORTIC ANEURYSMS. THE FOLLOWING MALFUNCTIONS WERE OBSERVED; TYPE II ENDOLEAK, UNKNOWN ENDOLEAK THE FOLLOWING ADVERSE EVENTS WERE OBSERVED; RUPTURE, ANEURYSM ENLARGEMENT, RTAD, SINE, RE-INTERVENTION. PATIENT DEATHS WERE REPORTED BUT THERE IS 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
    1213801 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R