BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 2982871 · Received February 28, 2013

    Report

    Report Number
    2025587-2013-00039
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    December 4, 2012
    Report Date
    February 22, 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
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION NOTED THE LEFT CUSP WAS CLOSED. THE RIGHT AND NON-CORONARY CUSPS WERE IN THE OPEN POSITION. ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE EXCEPT WHERE HOST TISSUE EXTENDED ON THE INFLOW AND OUTFLOW. TWO TEARS AND ABRASIONS THROUGH THE FREE MARGIN AND LUNULA OF THE RIGHT CUSP APPEARED TO BE DUE TO CONTACT WITH THE BIAS CLOTH ALONG THE OUTFLOW RAIL ADJACENT TO THE LEFT RIGHT AND RIGHT NON-CORONARY STENT POSTS. A SMALL ABRASION THROUGH THE LUNULA OF THE NON-CORONARY CUSP APPEARED TO BE DUE TO CONTACT WITH THE BIAS CLOTH ALONG THE OUTFLOW RAIL ADJACENT TO THE LEFT RIGHT STENT POST. THE FREE MARGIN AND LUNULA OF THE LEFT CUSP WAS ADHERED TO THE HOST TISSUE ON THE OUTFLOW. THE LEFT RIGHT AND RIGHT NON-CORONARY COMMISSURES WERE INTACT. THE NON-CORONARY LEFT COMMISSURE APPEARED TO HAVE BEEN INTACT PRIOR TO EXPLANT. MINOR TEARS ASSOCIATED WITH POSSIBLE FORCEPS WERE NOTED ON THE TOP OF THE COMMISSURE. EXPLANT DAMAGE WAS OBSERVED ON THE TOP OF THE LEFT RIGHT COMMISSURAL AREA BUT NOT THE ATTACHMENT. REMNANTS OF GLISTENING OFF WHITE PANNUS LINED THE TISSUE AND BASE STITCHING ADJACENT TO ALL CUSPS, INTO ALL INFERIOR COAPTIVE AREAS, AND 1 TO 3 MM ONTO ALL CUSPS. PANNUS WAS OBSERVED ON THE OUTFLOW EDGE OF THE SEWING RING, ONTO THE OUTFLOW RAIL ADJACENT TO THE LEFT AND RIGHT CUSPS. PANNUS WAS NOTED ON THE FREE MARGIN AND LUNULA OF THE LEFT CUSP EXTENDING SLIGHTLY ONTO THE HOST TISSUE ON THE OUTFLOW. AN UNKNOWN AMOUNT OF PANNUS APPEARED TO HAVE BEEN REMOVED ON THE INFLOW AND OUTFLOW DURING EXPLANT. TAN VEGETATIVE HOST TISSUE FILLED AND STIFFENS THE LEFT CUSP ON THE OUTFLOW. A THIN LAYER OF TAN VEGETATIVE HOST TISSUE APPEARED TO COVER THE LEAFLETS ON THE INFLOW. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION IN THE VALVE AND/OR HOST TISSUE. CONCLUSIONS: BASED ON ANALYSIS, TEARS AND ABRASIONS WERE CONFIRMED WHICH APPEARED TO HAVE BEEN DUE TO CONTACT WITH THE BIAS CLOTH. IN ADDITION, THE OBSERVED PANNUS AND VEGETATION ON THE LEAFLETS CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. PANNUS IS GENERALLY RELATED TO PATIENT CONDITION. IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR POSSIBLE ENDOCARDITIS APPROXIMATELY 18 MONTHS AFTER IMPLANT. CASES THAT OCCUR MORE THAN 12 MONTHS AFTER THE PROCEDURE ARE CALLED LATE PROSTHETIC-VALVE ENDOCARDITIS AND ARE LARGELY COMMUNITY-ACQUIRED. THE REPORTED "SUSPECTED PARAVALVULAR LEAK" COULD NOT BE CONFIRMED DURING THE ANALYSIS. BASED ON THE DEVICE HISTORY REVIEW OF THIS PRODUCT, THERE WAS NO ISSUE IDENTIFIED REGARDING MANUFACTURING AND STERILIZATION. ALL DEVICES UNDER THIS STERILITY LOT WERE MANUFACTURED PER APPROVED AND RELEASED MANUFACTURING PROCESSES AND THE DEVICES MET ALL APPLICABLE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION. THERE WERE NO OTHER COMPLAINTS REPORTED FOR INFECTION/ENDOCARDITIS UNDER THIS STERILITY LOT. IN CONCLUSION, THE CLINICAL OBSERVATION FOR ENDOCARDITIS WAS CONFIRMED; HOWEVER, WAS LIKELY COMMUNITY-ACQUIRED. IN ADDITION, THE CUSPAL TEARS REPORTED WERE LIKELY CAUSED BY A COMBINATION OF THE ENDOCARDITIS IN COMBINATION WITH CONTACT WITH THE BIAS CLOTH, WHICH IS USUALLY RELATED TO PATIENT ANATOMY OR IMPLANT TECHNIQUE. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT EIGHTEEN MONTHS FOLLOWING THE IMPLANT OF THIS BIOPROSTHETIC VALVE THE PATIENT WAS TREATED FOR POSSIBLE ENDOCARDITIS. THE PATIENT WAS TREATED WITH A SIX WEEK COURSE OF ANTIBIOTICS FOR (B)(6). ALSO, ECHOCARDIOGRAM RESULTS REVEALED HIGH GRADIENT (MEAN 58MMHG; PEAK 110MMHG), AND REGURGITATION (SUSPECTED PARAVALVULAR). TWENTY-TWO MONTHS FOLLOWING IMPLANT THE VALVE WAS EXPLANTED AND REPLACED WITH A PERICARDIAL VALVE WITH NO FURTHER ADVERSE PATIENT EFFECTS REPORTED. UPON EXPLANT THERE WAS NO PARAVALVULAR LEAK, BUT RUPTURE OF A VALVE CUSP WAS EVIDENT. THE VALVE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86063 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA 305

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R