BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1070926 · Received July 8, 2008

    Report

    Report Number
    2025587-2008-00057
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 3, 2008
    Report Date
    July 2, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECS WHEN RELEASED FOR DISTRIBUTION. ANALYSIS: THE VALVE WAS RETURNED IN A SMALL SPECIMEN CONTAINER WITH TAN SOLUTION, MOST LIKELY FORMALIN. THE LEAFLETS APPEAR SLIGHTLY STIFF, BUT FLEXIBLE AND INTACT. FURTHER INSPECTION REVEALED REMNANTS OF GLISTENING OFF-WHITE PANNUS REMAINED ATTACHED TO THE SEWING RING, TISSUE AND BASE STITCHING, EXTENDING INTO THE LEFT RIGHT INFERIOR COAPTIVE AREA, 1-5MM ONTO THE LEFT AND RIGHT CUSPS. RADIOGRAPHIC EXAMINATION DID NOT REVEAL ANY EVIDENCE OF MINERALIZATION IN THE VALVE TISSUE. CONCLUSION: REDUCED PERFORMANCE OF THE DEVICE ATTRIBUTED TO HOST TISSUE OVERGROWTH, A CONDITION ATTRIBUTED TO THE PT. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT REPORTED PT COMPLICATION..

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THE PT WITH THIS AORTIC BIOPROSTHETIC VALVE EXPERIENCED SHORTNESS OF BREATH WITH EXERCISE. THE VALVE WAS REMOVED AND REPLACED DUE TO STENOSIS AFTER BEING IMPLANTED FOR 15 MONTHS. UPON REMOVING THE VALVE, A SHELF OF FIBRIN WAS NOTED ON THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT). THE VALVE WAS RETURNED TO MEDTRONIC FOR ANALYSIS.

    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 44 YR Hospitalization| R