BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1201747 · Received October 10, 2008

    Report

    Report Number
    2025587-2008-00097
    Event Type
    Injury
    Date Received
    October 10, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 10, 2008
    Manufacturer
    THE HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEWED. DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. ANALYSIS: UPON RECEIPT, ALL LEAFLETS OF THE VALVE WERE STIFF BUT SLIGHTLY FLEXIBLE EXCEPT WHERE HOST TISSUE EXTENDED ON THE INFLOW OF ALL CUSPS AND LINED THE OUTFLOW OF THE NON-CORONARY CUSP. THICK PANNUS LINED THE SEWING RING ON THE INFLOW ALONG THE TISSUE AND BASE STITCHING, INTO ALL INFERIOR COAPTIVE AREAS AND EXTENDED 1 TO 3 MM ONTO ALL CUSPS SIGNIFICANTLY REDUCING THE INFLOW ORIFICE AREA. TAN THROMBOTIC APPEARING HOST MATERIAL PARTIALLY FILLED AND STIFFENED THE NON-CORONARY CUSP ON THE OUTFLOW. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION ON THE VALVE AND HOST TISSUE. THE DEVICE HISTORY RECORD FOR THIS VALVE WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. CONCLUSION: REDUCED PERFORMANCE OF THE VALVE ATTRIBUTED TO PANNUS OVERGROWTH, A CONDITION ATTRIBUTED TO THE PATIENT. THE VALVE WAS EXPLANTED AND REPLACED WITH A STENTLESS VALVE WITHOUT REPORTED PATIENT COMPLICATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS BIOPROSTHETIC AORTIC VALVE PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF SYNCOPE, APPROXIMATELY ONE YEAR POST IMPLANT. A TRANS-THORACIC ECHOCARDIOGRAM DEMONSTRATED GRADIENTS OF 70 /50MMHG. A STRESS ECHO WAS PERFORMED, WHICH DEMONSTRATED GRADIENTS OF 96/60MMHG. THE SURGEON ELECTED TO EXPLANT AND REPLACE THE VALVE WITH A STENTLESS AORTIC BIOPROSTHESIS. UPON EXPLANT, NO GROSS DEGENERATION WAS NOTED. THE VALVE WAS RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R