BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1841065 · Received September 15, 2010

    Report

    Report Number
    2025587-2010-00107
    Event Type
    Injury
    Date Received
    September 15, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT ATTRIBUTED TO PATIENT CONDITION. ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE EXCEPT WHERE HOST TISSUE EXTENDED ON THE INFLOW OF THE RIGHT CUSP. TEARS ON THE TUNICA OF THE NON-CORONARY AND LEFT CUSPS ALONG THE INFLOW MARGIN OF ATTACHMENT APPEARED TO BE DUE TO HOST TISSUE REMOVAL DURING EXPLANT. GLISTENING OFF-WHITE PANNUS LINED THE EXISTING SEWING RING ON THE INFLOW ADJACENT TO THE RIGHT CUSP EXTENDING TO THE LEFT RIGHT AND RIGHT NON-CORONARY INFERIOR COAPTIVE AREAS AND 1 TO 3 MM ONTO THE RIGHT CUSP REDUCING THE INFLOW ORIFICE AREA. PANNUS ON THE OUTFLOW RAILS OF THE LEFT AND RIGHT CUSPS EXTENDED TO THE TOP OF THE LEFT RIGHT STENT POST TO THE OUTFLOW MARGIN OF ATTACHMENT ADJACENT TO THE LEFT RIGHT COMMISSURAL AREA. AN UNKNOWN AMOUNT OF PANNUS APPEARED TO HAVE BEEN REMOVED ON THE INFLOW AND OUTFLOW DURING EXPLANT. RADIOGRAPHY SHOWS REMNANTS OF MINERALIZATION IN THE HOST TISSUE ALONG THE RIGHT CUSP EXTENDING TO THE LEFT RIGHT AND RIGHT NON-CORONARY COMMISSURES. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. REDUCED PERFORMANCE OF THE VALVE IS ATTRIBUTED TO HOST TISSUE OVERGROWTH. THESE FINDINGS ARE GENERALLY CONSIDERED A PATIENT RELATED CONDITION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE, IMPLANTED 3.5 YEARS, WAS EXPLANTED DUE TO AORTIC STENOSIS.

    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