BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 9376550 · Received November 26, 2019

    Report

    Report Number
    2015691-2019-04405
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    November 4, 2019
    Report Date
    November 4, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #2800; BRAND NAME: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS; PMA #P860057/S001. 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 WITH STRUCTURAL DETERIORATION. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT. THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO AN EDWARDS MANUFACTURING DEFICIENCY AND/OR ONE WAS NOT CONFIRMED THROUGH INVESTIGATION. 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

    EDWARDS RECEIVED NOTIFICATION THAT THIS PATIENT WITH A 23MM 2900 AORTIC PERICARDIAL VALVE HAS BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, FIVE (5) MONTHS DUE TO CALCIFIC STRUCTURAL DETERIORATION LEADING TO AORTIC CENTRAL REGURGITATION. ON TOE, THE BIORPSTHETIC AORTIC VALVE WAS WELL-SEATED AND LEAFLETS APPEAR TO OPEN WELL. THERE WAS MODERATE CENTRAL AORTIC REGURGITATION WITH NO EVIDENCE OF PARAVALVULAR LEAK. PATIENT WAS AWAITING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174918 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 290023MM

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR