BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 10055834 · Received May 14, 2020

    Report

    Report Number
    2025587-2020-01628
    Event Type
    Death
    Date Received
    May 14, 2020
    Date of Event
    February 22, 2020
    Report Date
    May 14, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    UDI-DI
    00643169594845
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 310C25, SERIAL/LOT #: (B)(4), UBD: 01-JUN-2024, UDI#: (B)(4), PMA/510(K): P990064. PRODUCT ANALYSIS: THE DEVICES REMAIN IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THIS SURGERY A BIOPROSTHETIC MITRAL VALVE WAS IMPLANTED IN THE MITRAL POSITION, AND ANOTHER BIOPROSTHETIC MITRAL VALVE WAS IMPLANTED IN THE TRICUSPID POSITION. IMMEDIATELY FOLLOWING THIS, AN INTRA-AORTIC BALLOON PUMP (IABP) WAS IMPLANTED. ATTEMPTS AT WEANING THE PATIENT FROM CARDIOPULMONARY BYPASS WERE UNSUCCESSFUL, AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INITIATED. AIR ENTERED THE AORTIC PORTION OF THE ECMO CIRCUIT, WHICH WAS A FATAL COMPLICATION. THE PATIENT DIED PRIOR TO LEAVING THE OPERATING ROOM. THERE IS NO INFORMATION TO SUGGEST THAT THE FUNCTION OF A MEDTRONIC DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520260 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 310C27 00643169594845

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death