BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 11138389 · Received January 8, 2021

    Report

    Report Number
    9612164-2021-00085
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Date of Event
    April 6, 2020
    Report Date
    January 8, 2021
    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; EARLY AND MIDTERM OUTCOMES OF IN SITU LASER FENESTRATION DURING THORACIC ENDOVASCULAR AORTIC REPAIR FOR ACUTE AND SUBACUTE AORTIC ARCH DISEASES AND ANALYSIS OF ITS COMPLICATIONS LI C, XU P, HUA Z, JIAO Z, CAO H, LIU S, ZHANG WW, LI Z. JOURNAL OF VASCULAR SURGERY. 2020 NOV;72(5):1524-1533. DOI: 10.1016/J.JVS.2020.01.072. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT AND ENDURANT AND NON MDT STENT GRAFTS WERE IMPLANTED IN THE THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) OF ACUTE AND SUBACUTE COMPLEX AORTIC ARCH DISEASES WHERE ALSO IN SITU LASER FENESTRATION (ISLF) OF THE STENT GRAFTS WAS CARRIED OUT. THE FOLLOWING MALFUNCTIONS OCCURRED; ENDOLEAKS TYPE IA, IB, II, IIIA AND IIIC THE FOLLOWING ADVERSE EVENTS OCCURRED; DISSECTION, HEMATOMA, STROKE, EMBOLISM, RUPTURE. PATIENT DEATHS WERE ALSO REPORTED BUT THERE IS NO CAUSAL LINK THAT A MDT STENT GRAFT CAUSED OR CONTRIBUTED TO THESE DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39252 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR