BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS SUPRAANNULAR BIOPROSTHESIS

    MDR report key: 7802091 · Received August 21, 2018

    Report

    Report Number
    2015691-2018-03466
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    July 27, 2018
    Report Date
    July 27, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT SUBMITTED TO INCLUDE ADDITIONAL INFORMATION RECEIVED THROUGH FOLLOW-UP. ALTHOUGH BIOPROSTHETIC VALVES HAVE BEEN PROVEN TO HAVE EXCELLENT LONG TERM DURABILITY, FAILURE DOES OCCUR IN A SMALL NUMBER OF VALVES. REPLACEMENT OF A BIOPROSTHETIC VALVE OVER TIME IS MORE LIKELY DUE TO STRUCTURAL VALVE DETERIORATION (SVD) WHICH OCCURS AS A RESULT OF STENOSIS (FROM CALCIFICATION OR HOST TISSUE OVERGROWTH), DEHISCENCE, FIBROSIS OR NON-CALCIFIC DEGENERATION. CALCIFICATION IS A WELL-RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION. 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 BIOPROSTHESES FROM CALCIFYING. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINED IMPLANTED. THEREFORE, THE ROOT CAUSE FOR THE CALCIFICATION AND REGURGITATION REMAINS INDETERMINABLE. HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    EDWARDS RECEIVED ADDITIONAL INFORMATION THROUGH FOLLOW UP WITH THE HEALTHCARE PROVIDER THAT THE VALVE WAS DEGENERATED BOTH BECAUSE OF STENOSIS AND BECAUSE A LEAFLET OF SURGICAL VALVE WAS NOT MOVING (CALCIUM ON IT). THE VALVE ALSO HAD CENTRAL INSUFFICIENCY.

    Additional Manufacturer Narrative · 1

    MODEL #: THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #6625-LP; BRAND NAME: CARPENTIER-EDWARDS® DURAFLEX® LOW PRESSURE MITRAL BIOPROSTHESIS; PMA P870077. ALTHOUGH BIOPROSTHETIC VALVES HAVE BEEN PROVEN TO HAVE EXCELLENT LONG TERM DURABILITY, FAILURE DOES OCCUR IN A SMALL NUMBER OF VALVES. REPLACEMENT OF A BIOPROSTHETIC VALVE OVER TIME IS MORE LIKELY DUE TO STRUCTURAL VALVE DETERIORATION (SVD) WHICH OCCURS AS A RESULT OF STENOSIS (FROM CALCIFICATION OR HOST TISSUE OVERGROWTH), DEHISCENCE, FIBROSIS OR NON-CALCIFIC DEGENERATION AND/OR ENDOCARDITIS. STENOSIS, WHICH DEVELOPS PROGRESSIVELY OVER TIME, CAN BE DUE TO A NUMBER OF ISSUES. ADDITIONALLY, THERE CAN BE A NUMBER OF POTENTIAL KNOWN AND UNKNOWN PATIENT RELATED CONTRIBUTING FACTORS. SVD, A COMMON REASON FOR BIOPROSTHESIS EXPLANT OR REOPERATION, ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFIC AND NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES, OCCURRING SINGULARLY OR CONCOMITANTLY, MAY CONTRIBUTE TO STENOSIS AND/OR REGURGITATION. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR STENOSIS. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINED IMPLANTED. THEREFORE, THE ROOT CAUSE FOR THE DEGENERATION, REGURGITATION, AND STENOSIS REMAINS INDETERMINABLE. HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT. THE DEVICE HISTORY RECORD (DHR) WAS NOT ABLE TO BE REVIEWED AS THE DEVICE SERIAL NUMBER WAS NOT PROVIDED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL 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 A (B)(6) PATIENT WITH A 27MM MITRAL VALVE, UNDERWENT A VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROX EIGHT (8) YEARS AND SIX (6) MONTHS DUE TO DEGENERATION LEADING TO STENOSIS AND MITRAL INSUFFICIENCY. A 26MM TRANSCATHETER VALVE WAS IMPLANTED VIA THE TRANSAPICAL APPROACH. THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643858 CARPENTIER-EDWARDS SUPRAANNULAR BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 665027MM

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R