BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 7191681 · Received January 15, 2018

    Report

    Report Number
    2015691-2018-00192
    Event Type
    Injury
    Date Received
    January 15, 2018
    Date of Event
    December 22, 2017
    Report Date
    December 22, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORT OF STENOSIS SECONDARY TO CALCIFICATION WAS CONFIRMED. X-RAY DEMONSTRATED HEAVY CALCIFICATION ON ALL THREE LEAFLETS, COMMISSURE 3 BENT, AND FRAME DISTORTION. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AND INTO THE ORIFICE AT THE GREATEST DISTANCE OF APPROXIMATELY 3MM ON THE INFLOW AND 5MM ON THE OUTFLOW ASPECT OF LEAFLET 3. HOST TISSUE ON THE STENT CIRCUMFERENCE AND FRAME WAS HEAVY AT THE INFLOW AND OUTFLOW ASPECT. HOST TISSUE FUSED LEAFLETS 2 AND 3 BY APPROXIMATELY 2MM NEAR COMMISSURE 3 ON THE OUTFLOW ASPECT. CALCIFICATION AND HOST TISSUE RESTRICTED LEAFLET MOBILITY AND LED TO STENOSIS. LEAFLET 1 HAD A 3MM NON-TRANSMURAL TEAR AND LEAFLET 2 HAD A 4MM NON-TRANSMURAL TEAR; BOTH NEAR COMMISSURE 2. SERRATED MARKING WERE OBSERVED NEAR THE TEARS AND ON COMMISSURE 2. THE WIREFORM WAS EXPOSED ON COMMISSURE 1.

    Additional Manufacturer Narrative · 1

    THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #8300AB; BRAND NAME: EDWARDS INTUITY ELITE VALVE SYSTEM; PMA #P150036. BIOPROSTHETIC TISSUE VALVES CAN DETERIORATE WITH TIME AND EVENTUALLY FAIL CONTRIBUTING TO REGURGITATION AND/OR STENOSIS. STRUCTURAL VALVE DETERIORATION (SVD) IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANTS/REPLACEMENTS AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. IN THIS CASE, CALCIFICATION WAS INDICATED. CALCIFICATION PLAYS A MAJOR ROLE IN THE FAILURE OF BIOPROSTHETIC HEART VALVES. CALCIFICATION OF VALVES OCCURS AS A PROGRESSIVE, TIME-DEPENDENT PROCESS. TISSUE VALVE CALCIFICATION IS INITIATED PRIMARILY WITHIN RESIDUAL CELLS THAT HAVE BEEN DEVITALIZED. INITIAL CALCIFICATION DEPOSITS EVENTUALLY ENLARGE AND GROW INTO A MASS, WHICH STIFFEN AND WEAKEN THE TISSUE AND THEREBY CAUSE THE PROSTHESIS TO MALFUNCTION. THE MINERALIZATION OF A BIOMATERIAL IS GENERALLY ENHANCED AT THE SITES OF INTENSE MECHANICAL DEFORMATIONS GENERATED BY MOTION, SUCH AS THE POINTS OF FLEXION IN HEART VALVES. ULTIMATELY, THE RESULT OF CALCIFICATION IS VALVE FAILURE DUE TO TEARING OR STENOSIS. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.), MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE, AND GLUTARALDEHYDE FIXATION OF TISSUE. OF THESE, THE FIXATION PROCESS IS A RELATIVELY MINOR CONTRIBUTOR TO CALCIFICATION FOR EDWARDS' TISSUE VALVES DUE TO ANTI-CALCIFICATION TREATMENTS DURING MANUFACTURING. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESIS FROM CALCIFYING. THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE INFORMATION. HOWEVER, THE CALCIFICATION OBSERVED IN THIS CASE WAS MOST LIKELY DUE TO A PROGRESSION OF THE PATIENT¿S UNDERLYING VALVULAR DISEASE PATHOLOGY COMBINED WITH THE PATIENT¿S OTHER UNDERLYING RISK FACTORS. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLINICAL TRIAL PATIENT WITH A 21MM PERICARDIAL AORTIC VALVE UNDERWENT A VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, 10 MONTHS DUE TO AORTIC STENOSIS SECONDARY TO CALCIFICATION. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM EDWARDS PERICARDIAL AORTIC VALVE. PER MEDICAL RECORDS, THE 21MM VALVE WAS HEAVILY CALCIFIED. IT WAS EXCISED. THERE WAS ABSOLUTELY NO PARAVALVULAR LEAK. A 23MM VALVE WAS THEN PLACED IN A SUPRA-ANNULAR POSITION WITH PLEDGETS ON THE VENTRICULAR SIDE. THE VALVE WAS SECURED DOWN USING A COR-KNOT DEVICE. THE VALVE WAS WELL-SEATED. THE ROOT WAS COPIOUSLY IRRIGATED FOR DEBRIS. THERE WERE NO COMPLICATIONS NOTED. POST OPERATIVE TEE REVEALED LVEF 60%, LOW NORMAL RV FUNCTION. THE PATIENT WAS TRANSPORTED TO THE SICU IN CRITICAL CONDITION. IN THE SICU, THE PATIENT DID WELL AND WAS WEANED OFF ALL PRESSORS AND INOTROPIC SUPPORT. ON POD #7, THE PATIENT WENT INTO RAF AND WAS CHEMICALLY CONVERTED AND STARTED ON SYSTEMIC ANTICOAGULATION. THE PATIENT WAS DISCHARGED HOME ON POD #11 IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34647 SEE H10 TISSUE, HEART-VALVE LWR EDWARDS LIFESCIENCES 8300ACA21

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R