BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1902497 · Received November 11, 2010

    Report

    Report Number
    2025587-2010-00136
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 28, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), METHOD: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT ATTRIBUTED TO PT RELATED CONDITION. ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, THE VALVE APPEARED TO HAVE BEEN DAMAGED DURING EXPLANT AND/OR DURING THE HISTOPATHOLOGY SAMPLING PROCESS. THE STENT WAS BROKEN ADJACENT TO THE LEFT CUSP. ALL EXISTING LEAFLETS WERE STIFF DUE TO TAN THROMBOTIC HOST TISSUE ON THE OUTFLOW. THE NON-CORONARY CUSP WAS PROLAPSED DUE TO THE ADHERENCE OF THROMBOTIC HOST TISSUE ON THE OUTFLOW. REMNANTS OF GLISTENING OFF-WHITE PANNUS REMAINED ATTACHED TO THE SEWING RING ON THE INFLOW ADJACENT TO THE NON-CORONARY CUSP, ALONG THE TISSUE AND BASE STITCHING ADJACENT TO THE RIGHT AND NON-CORONARY CUSPS, TO THE INFLOW MARGIN OF ATTACHMENT OF THE LEFT CUSP, INTO THE RIGHT NON-CORONARY AND NON-CORONARY LEFT INFERIOR COAPTIVE AREAS EXTENDING 1 TO 2 MM ON ALL EXISTING LEAFLETS. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION IN THE VALVE AND/OR HOST TISSUE. 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 THROMBUS AND HOST TISSUE OVERGROWTH. THESE FINDINGS ARE GENERALLY CONSIDERED A PT RELATED CONDITION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS BIOPROSTHETIC VALVE, IMPLANTED THREE MONTHS, WAS EXPLANTED DUE TO A GRADIENT.

    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