BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT CAPTIVIA UNK

    MDR report key: 11587826 · Received March 30, 2021

    Report

    Report Number
    9612164-2021-01234
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    September 11, 2020
    Report Date
    March 30, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; PREVENTION OF RETROGRADE ASCENDING AORTIC DISSECTION BY CARDIAC PACING DURING HYBRID SURGERY FOR ZONE 0 AORTIC ARCH REPAIR CHASSIN-TRUBERT L, OZDEMIR BA, ROUSSEL A, DESSERTENNE G, CASTIER Y, LUDOVIC C, ALRIC P ANNALS OF VASCULAR SURGERY. 2021 71:48-55. DOI: 10.1016/J.AVSG.2020.08.136. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT CAPTIVIA, TALENT AND NON MDT STENT GRAFTS WERE IMPLANTED IN ZONE 0 HYBRID AORTIC ARCH REPAIR PROCEDURES FOR VARIOUS AORTIC PATHOLOGIES. THE FOLLOWING MALFUNCTIONS WERE OBSERVED; ENDOLEAK THE FOLLOWING ADVERSE EVENTS WERE OBSERVED; DISSECTION, STROKE, ISCHEMIA, THROMBOSIS, RENAL INSUFFICIENCY, RESPIRATORY DISTRESS, ACCESS RELATED COMPLICATIONS, CARDIAC COMPLICATIONS (MYOCARDIAL INFRACTION, ARRHYTHMIA HEMOPERICARDIUM, HEMOMEDIASTINUM), HEMORRHAGE, NERVE LESION, RE-INTERVENTION PATIENT MORTALITY WAS 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
    489532 VALIANT CAPTIVIA UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-CAP

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR