BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 1082171 · Received July 24, 2008

    Report

    Report Number
    2025587-2008-00070
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    May 27, 2008
    Report Date
    July 24, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS - UPON RECEIPT, THE LEFT AND RIGHT CUSPS ARE SLIGHTLY STIFF, BUT FLEXIBLE. THE NON-CORONARY CUSP IS STIFF DUE TO HOST TISSUE ON THE OUTFLOW. GLISTENING OFF WHITE PANNUS FILLS AND STIFFENS THE NON-CORONARY CUSP ON THE OUTFLOW EXTENDING ONTO THE RIGHT NON-CORONARY AND NON-CORONARY LEFT COMMISSURES. PANNUS EXTENDS OVER THE TISSUE AND BASE STITCHING ADJACENT TO THE RIGHT AND NON-CORONARY CUSPS INTO ALL INFERIOR COAPTIVE AREAS WITH A THIN LAYER EXTENDING 1 TO 4 MM ONTO THE LEFT AND RIGHT CUSPS REDUCING THE INFLOW ORIFICE AREA. RADIOGRAPHY SHOWS NO EVIDENCE OF MINERALIZATION IN THE VALVES AND HOST TISSUE. THE DHR FOR THIS DEVICE WAS REVIEWED AND NO ISSUES WERE SHOWN THAT WOULD HAVE IMPACTED THIS EVENT. CONCLUSION: REDUCED PERFORMANCE OF THE DEVICE ATTRIBUTED TO A HOST TISSUE OVERGROWTH, A KNOWN CONDITION ATTRIBUTED TO THE PT. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT REPORTED PT COMPLICATION.

    Description of Event or Problem · 1

    MEDTRONIC REVEALED INFORMATION THAT THIS BIOPROSTHETIC MITRAL VALVE WAS EXPLANTED AFTER 27 MOS, DUE TO STENOSIS. UPON EXPLANT, PANNUS OVERGROWTH WAS OBSERVED ON THE VALVE. IT WAS REPORTED THAT THERE WERE NO PT COMPLICATIONS.

    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 39 YR Hospitalization| R