BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 1000968 · Received February 15, 2008

    Report

    Report Number
    2025587-2008-00008
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    December 22, 2007
    Report Date
    January 18, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. THE PRODUCT HAS BEEN RETURNED FOR ANALYSIS. TO DATE, THE ANALYSIS HAS NOT BEEN COMPLETED. UPON COMPLETION OF THE ANALYSIS, A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC MITRAL VALVE EXHIBITED SEVERE REGURGITATION TEN DAYS POST-OP DUE TO THROMBUS FORMATION. IT WAS REPORTED THAT LEAFLET ABNORMALITIES WERE OBSERVED. HOWEVER, THE EXACT NATURE OF THE ABNORMALITIES WAS NOT SPECIFIED. THE VALVE WAS REPLACED WITH A SIMILAR VALVE, WITHOUT REPORTED COMPLICATION. IT WAS REPORTED THAT THE PATIENT EXPIRED 3 WEEKS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES, INC. 310 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R