BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 1082343 · Received July 23, 2008

    Report

    Report Number
    2025587-2008-00068
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    May 19, 2008
    Report Date
    July 22, 2008
    Manufacturer
    MEDTRONIC HEART VALVE, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. ANALYSIS: THE DEVICE HISTORY RECORD FOR THIS DEVICE WAS REVIEWED AND NO ISSUES WERE SHOWN THAT WOULD HAVE IMPACTED THIS EVENT. THE ANALYSIS OF THE DEVICE SHOWS THAT THE EVENT WAS CAUSED BY OVER-RATCHETING THE CINCHING SUTURES. CONCLUSION: DEVICE FAILURE ATTRIBUTED TO USER INTERFACE. ALTHOUGH THE PRODUCT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, INFO OBTAINED IN 2008 INDICATES THAT THE MALFUNCTION MEETS THE REPORTABLE MALFUNCTION REQUIREMENTS STIPULATED. CONSEQUENTLY, THIS MDR IS BEING SUBMITTED IN ACCORDANCE WITH REGULATION. MEDTRONIC CONTINUES TO MONITOR FIELD PERFORMANCE TO DEFECT SIMILAR EVENTS.

    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 NOT USED, AND THERE WAS NO PT INVOLVEMENT WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVE, INC. 310 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other