BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1025997 · Received April 4, 2008

    Report

    Report Number
    2025587-2008-00024
    Event Type
    Injury
    Date Received
    April 4, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: METHOD- DEVICE HISTORY REVIEWED. RESULTS - DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. ANALYSIS: ALL LEAFLETS ARE SLIGHTLY STIFF BUT FLEXIBLE, GLISTENING OFF WHITE PANNUS EXTENDS OVER THE TISSUE AND BASE STITCHING INTO THE INFERIOR CAPTIVE AREAS AND 1 TO 2MM ONTO ALL CUSPS REDUCING THE INFLOW ORIFICE AREA. RADIOGRAPHY SHOWS NO EVIDENCE OF MINERALIZATION ON THE VALVE AND HOST TISSUE. CONCLUSION: THE GROSS ANALYSIS INDICATES THAT THE STENOSIS WAS DUE TO PANNUS OVERGROWTH, A CONDITION ATTRIBUTED TO THE PT.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS BIOPROSTHETIC AORTIC VALVE WAS REMOVED DUE TO REGURGITATION, STENOSIS (PEAK 94 MMHG, MEAN 48 MMHG) NOTED BY ECHO. UPON EXPLANT, THE VALVE APPEARED TO BE NORMAL AND HAD BEEN IMPLANTED INTRA-ANNULARLY. VALVE EOA: 85 CM SQ; B.S.A.: 2.2 M SQ. THE SURGEON EXPRESSED NO DISSATISFACTION WITH THE PERFORMANCE OF THE PRODUCT, AND THE DEVICE WAS CHANGED OUT WITH NO REPORTED ADVERSE PT EFFECT.

    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 79 YR Required Intervention