BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1082172 · Received July 24, 2008

    Report

    Report Number
    2127690-2008-00007
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    May 27, 2008
    Report Date
    July 24, 2008
    Manufacturer
    MEDTRONIC HEART VALVES
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. CONCLUSION ANALYSIS: THE NON-CORONARY CUSP IS SLIGHTLY STIFF, BUT FLEXIBLE. THE RIGHT CUSP IS STIFF DUE TO REDDISH TAN THROMBOTIC APPEARING HOST TISSUE ON THE OUTFLOW. THE LEFT CUSP IS STIFF, BUT SLIGHTLY FLEXIBLE; THICKENED POSSIBLY ASSOCIATED WITH THE TAN THROMBOTIC APPEARING HOST TISSUE ON THE OUTFLOW. THICK GLISTENING OFF WHITE PANNUS EXTENDS OVER THE TISSUE AND BASE STITCHING, MARGIN OF ATTACHMENT OF ALL CUSPS ON THE INFLOW, INTO ALL INFERIOR COAPTIVE AREAS AND 1 TO 2 MM ONTO ALL CUSPS REDUCING THE INFLOW ORIFICE AREA. RADIOGRAPHY SHOWS NO EVIDENCE OF MINERALIZATION ON THE VALVE AND HOST TISSUE. THE DHR FOR THIS DEVICE WAS REVIEWED AND NO ISSUES WERE SHOWN THAT WOULD HAVE IMPACTED THIS EVENT. CONCLUSION: THE ANALYSIS OF THE DEVICE SHOWS THAT THE EVENT WAS CAUSED BY THROMBUS, WHICH IS A KNOWN FAILURE MODE FOR BIOPROSTHETIC VALVES THAT IS ATTRIBUTED TO PT CONDITION. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT PT COMPLICATION.

    Description of Event or Problem · 1

    MEDTRONIC REC'D INFO THAT THIS BIOPROSTHETIC AORTIC VALVE EXHIBITED MILD REGURGITATION AND STENOSIS, WITH A MEAN GRADIENT OF 31 MMHG. THE DECISION WAS MADE TO EXPLANT THE VALVE. DURING REOPERATION, THE SURGEON DESCRIBED A FIBROUS GROWTH WITHIN TWO OF THE VALVE SINUSES, SUSPECTED TO BE THROMBUS. THE PHYSICIAN ALSO REPORTED THAT THE STENT POSTS WERE DEFLECTED INWARDLY, AFFECTING THE LEAFLET MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES 305 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R