BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1192703 · Received October 6, 2008

    Report

    Report Number
    2025587-2008-00096
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    July 17, 2008
    Report Date
    October 3, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD - DEVICE HISTORY REVIEWED. RESULTS - DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION - CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: THE USER INDICATED THAT THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. WITHOUT PRODUCT RETURN, ANALYSIS IS LIMITED TO REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWS THAT THIS PRODUCT MET MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: EXACT CAUSE OF THE EVENT CANNOT BE DETERMINED WITHOUT PRODUCT RETURN. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT REPORTED ADVERSE PT EFFECTS. THE EVENT HAS BEEN LOGGED FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS BIOPROSTHETIC AORTIC VALVE WAS EXPLANTED AFTER APPROX 4 YEARS OF SERVICE DUE TO PERIVALVULAR LEAK AND A TORN LEAFLET. NO ADVERSE PT EFFECTS WERE REPORTED. MEDTRONIC CONTACTED THE USER FACILITY TO DETERMINE IF THE PRODUCT WAS GOING TO BE RETURNED FOR ANALYSIS. THE HOSPITAL INDICATED THAT THE PRODUCT WILL NOT BE RETURNED.

    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 65 YR Hospitalization| R