BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 1082340 · Received July 23, 2008

    Report

    Report Number
    2025587-2008-00069
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    May 7, 2008
    Report Date
    July 22, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: OTHER - DEVICE HISTORY REVIEWED. RESULTS: OTHER - DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: OTHER - CAUSE OF EVENT CANNOT BE DETERMINED WITHOUT PRODUCT RETURN. ANALYSIS: TO DATE, THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. RETURN OF THE PRODUCT, HOWEVER, IS ANTICIPATED. WITHOUT PRODUCT RETURN, ANALYSIS IS LIMITED TO REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWS THAT THE PRODUCT MET MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: ALTHOUGH THE PRODUCT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, INFO OBTAINED ON JULY 15, 2008 INDICATES THAT THE MALFUNCTION MEETS THE REPORTABLE MALFUNCTION REQUIREMENTS. CONSEQUENTLY, THIS MDR IS BEING SUBMITTED IN ACCORDANCE WITH THE REGULATION. MEDTRONIC CONTINUES TO MONITOR FILED PERFORMANCE TO DETECT SIMILAR EVENT. WHEN THE PRODUCT IS RECEIVED, ANALYSIS WILL BE COMPLETED, AND A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS BIOPROSTHETIC MITRAL VALVE WAS ABANDONED PRIOR TO IMPLANT DUE TO A BROKEN RATCHETING SUTURE ON THE CINCHING HOLDER MECHANISM. THE VALVE WAS SUBSEQUENTLY NOT USED. THERE WAS NO PT INVOLVEMENT WITH THE ASSOCIATED EVENT.

    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 Other