BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1013296 · Received March 12, 2008

    Report

    Report Number
    2025587-2008-00020
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 11, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: OTHER - DEVICE HISTORY REVIEWED. RESULTS: OTHER - DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. ANALYSIS: THE VALVE WAS RECEIVED WITH THE STENT SLIGHTLY DISTORTED. THE RIGHT CUSP IS SLIGHTLY STIFF BUT FLEXIBLE. THE NON-CORONARY AND LEFT CUSPS ARE SLIGHTLY STIFF BUT FLEXIBLE EXCEPT WHERE TAN THROMBOTIC APPEARING HOST MATERIAL FILLS THE BELLY OF THE CUSPS EXTENDING TO THE MARGINS OF ATTACHMENT. SMALL TEARS AND ABRASIONS IN THE RIGHT CUSP LUNULA ADJACENT TO THE LEFT RIGHT AND RIGHT NON-CORONARY COMMISSURES APPEAR TO BE DUE TO BIAS WEAR ON THE OUTFLOW RAIL. GLISTENING OFF WHITE PANNUS EXTENDS OVER THE SEWING RING, TISSUE AND BASE STITCHING ADJACENT TO THE NON-CORONARY CUSP, INTO THE NON-CORONARY LEFT AND LEFT RIGHT INFERIOR COAPTIVE AREAS ALONG THE MARGIN OF ATTACHMENT OF THE RIGHT CUSP AND SLIGHTLY ONTO THE LEFT. PANNUS EXTENDS 1 TO 2 MM ONTO THE RIGHT AND NON-CORONARY CUSPS IN THE INFLOW. RADIOGRAPHY SHOWS REMNANTS OF MINERALIZATION IN THE HOST TISSUE ADJACENT TO THE RIGHT NON-CORONARY STENT POST. REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THIS PRODUCT MET MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: REDUCED PERFORMANCE OF THE DEVICE OCCURRED AND IS LIKELY ATTRIBUTED TO THE THROMBUS, BIAS WEAR, PANNUS FORMATION, AND MINERALIZATION. PT CONDITION LIKELY CAUSED/CONTRIBUTED TO THE REPORTED EVENT. DEVICE REPLACED WITH NO REPORTED ADVERSE PT EFFECTS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC AORTIC VALVE EXHIBITED AN INCREASE IN GRADIENTS AFTER APPROX 8 MONTHS OF SERVICE. NO SYMPTOMS WERE REPORTED. THE SURGEON ELECTED TO EXPLANT AND REPLACE THE VALVE, WHICH WAS PERFORMED WITHOUT REPORTED COMPLICATION.

    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 77 YR Required Intervention