BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 1070927 · Received July 8, 2008

    Report

    Report Number
    2025587-2008-00056
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 3, 2008
    Report Date
    July 2, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: TO DATE, THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. WITHOUT PRODUCT RETURN, ANALYSIS IS LIMITED TO REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWS THAT THE PRODUCT MFG SPECS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: EXACT CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME, AS THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. RETURN OF THE DEVICE IS ANTICIPATED. UPON RECEIPT, A THOROUGH INVESTIGATION WILL BE COMPLETED, AND A FOLLOW UP REPORT WILL BE SUBMITTED. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT REPORTED PT COMPLICATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THE PT WITH THIS BIOPROSTHETIC MITRAL VALVE EXHIBITED SHORTNESS OF BREATH. DIAGNOSTIC TESTING DEMONSTRATED MITRAL REGURGITATION. THE DEVICE WAS SUBSEQUENTLY EXPLANTED IN A DUAL VALVE REPLACEMENT PROCEDURE, AND WAS REPLACED WITHOUT REPORTED PT COMPLICATION. THE AORTIC VALVE IS CONTAINED IN MDR 2025587200800055.

    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 73 YR Hospitalization| R