BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC

    MDR report key: 3190633 · Received June 26, 2013

    Report

    Report Number
    2025587-2013-00101
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, THE VALVE WAS DISTORTED; OVAL SHAPED. ALL LEAFLETS WERE IN THE CLOSED POSITION WITH A SLIGHT GAP BETWEEN THE COAPTIVE RIDGES OF THE NON-CORONARY CUSP AND THE OTHER TWO. ALL LEAFLETS WERE STIFF DUE TO HOST TISSUE ON THE OUTFLOW. A LARGE TEAR IN THE TUNICA OF THE RIGHT CUSP ALONG THE INFLOW MARGIN OF ATTACHMENT APPEARED TO BE ASSOCIATED WITH THE REMOVAL OF HOST TISSUE DURING EXPLANT. THE FREE MARGIN OF THE NON-CORONARY CUSP WAS FOLDED BACK AND ADHERED TO THE HOST TISSUE ON THE OUTFLOW RESULTING WITH A SMALL GAP AT THE POINT OF COAPTATION. ALL COMMISSURES APPEARED INTACT. A REMNANT OF PANNUS REMAINED ATTACHED TO THE NON-CORONARY CUSP EXTENDING 1 TO 2.5 MM ONTO THE INFLOW SHOWING EVIDENCE THE INFLOW ORIFICE AREA MAY HAVE BEEN REDUCED. TRACES OF PANNUS WERE OBSERVED ON THE INFLOW OF SEWING RING ADJACENT TO THE NON-CORONARY AND LEFT CUSPS. PANNUS WAS NOTED ALONG THE SEWING RING ON THE OUTFLOW, TO THE OUTFLOW RAIL OF THE LEFT CUSP AND BACKS OF NON-CORONARY LEFT AND LEFT RIGHT STENT POSTS. AN UNKNOWN AMOUNT OF PANNUS APPEARED TO HAVE BEEN REMOVED ON THE INFLOW AND OUTFLOW DURING EXPLANT. TAN THROMBOTIC APPEARING HOST TISSUE FILLED AND STIFFENED ALL CUSPS ON THE OUTFLOW. RADIOGRAPHY SHOWED TRACE MINERALIZATION IN THE LEFT CUSP AND OUTFLOW RAIL OF THE NON-CORONARY CUSP. CONCLUSION: THE REDUCED PERFORMANCE OF THE VALVE WAS ATTRIBUTED TO A COMBINATION OF PANNUS OVERGROWTH AND THROMBUS FORMATION; THESE ARE GENERALLY CONSIDERED PATIENT-RELATED CONDITIONS. IN ADDITION, THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS VALVE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED TO DISTRIBUTION. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE, IMPLANTED 20 MONTHS, WAS EXPLANTED DUE TO HIGH GRADIENTS AND STENOSIS. PRIOR TO THE EXPLANT PROCEDURE, ECHOCARDIOGRAM DEMONSTRATED STENOSIS, PEAK GRADIENT OF 98MM/HG, MEAN GRADIENT OF 67MM/HG, VALVE (B)(4) OF 0.6CM2. THE PATIENT WAS EXPERIENCING RECURRENT SYMPTOMS OF SHORTNESS OF BREATH. IN ADDITION, THE PATIENT WAS REFERRED FOR RIGHT AND LEFT HEART CATHETERIZATION, WHICH CONFIRMED THAT THE STENOSIS WAS SIGNIFICANT TO WARRANT VALVE REPLACEMENT. THE VALVE WAS REPLACED WITH A MECHANICAL VALVE OF ANOTHER MANUFACTURER AND RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE HOSPITAL PATHOLOGY FOUND FIBRINOUS DEBRIS WITH NEUTROPHILS AND NORMALLY FUNCTIONING LEAFLETS. CULTURES WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291516 MOSAIC HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA 305

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R