BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1033865 · Received April 24, 2008

    Report

    Report Number
    2025587-2008-00029
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 25, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: THIS DEVICE HAS BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. TO DATE, THE ANALYSIS OF THE PRODUCT HAS NOT BEEN COMPLETED. UPON COMPLETION OF THE ANALYSIS, A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA. CONCLUSION: REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THIS PRODUCT MET MFG SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE VALVE WILL BE ANALYZED, AND UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED. THE DEVICE WAS REPLACED WITHOUT REPORTED COMPLICATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS BIOPROSTHETIC AORTIC VALVE EXHIBITED A PARAVALVULAR LEAK 18 DAYS POST IMPLANT. THE DECISION WAS MADE TO EXPLANT AND REPLACE THE VALVE, WHICH WAS PERFORMED WITHOUT REPORTED COMPLICATION. NO SYMPTOMS OR ADVERSE PT OUTCOMES WERE REPORTED.

    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 66 YR Required Intervention