BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIC SURGICAL VALVE, 23MM

    MDR report key: 17488060 · Received August 9, 2023

    Report

    Report Number
    MW5120784
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    May 25, 2023
    Report Date
    June 12, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A VALVE IN VALVE PROCEDURE WAS PERFORMED, IMPLANTING A 23MM SAPIEN 3 ULTRA RESILIA VALVE WITHIN A FAILED 23MM MOSAIC SURGICAL VALVE, SERIAL NUMBER (B)(6). EW REFERENCE NUMBER: (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905162 MOSAIC SURGICAL VALVE, 23MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown