BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1212092 · Received October 23, 2008

    Report

    Report Number
    2025587-2008-00099
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 13, 2008
    Report Date
    October 23, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: EXACT CAUSE OF EVENT CANNOT BE DETERMINED. H3. ANALYSIS: TO DATE, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, AND THE OPERATIVE ECHOS HAVE NOT BEEN RECEIVED. WITHOUT THIS INFO, ANALYSIS IS LIMITED TO REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWS THAT THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: NO DEFINITIVE CONCLUSIONS CAN BE DRAWN AT THIS TIME, AS NEITHER THE DEVICE NOR THE OPERATIVE ECHOS HAVE BEEN RECEIVED FOR EVAL. ADDITIONAL INFO HAS BEEN REQUESTED. SHOULD AN ECHO BE OBTAINED, EVAL WILL BE PERFORMED, AND THE RESULTS WILL BE PROVIDED TO FDA.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS BIOPROSTHETIC AORTIC VALVE EXHIBITED REGURGITATION AS THE PT WAS COMING OFF BYPASS. THE SURGEON ELECTED TO EXPLANT AND REPLACE THE VALVE WITH A SIMILAR DEVICE, WHICH WAS PERFORMED WITHOUT REPORTED COMPLICATION. MEDTRONIC HAS REQUESTED COPIES OF THE OPERATIVE ECHOS DEMONSTRATING THE REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES, INC. 305 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention