BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT® AORTIC PERICARDIAL BIOPROSTHESIS

    MDR report key: 4646710 · Received March 31, 2015

    Report

    Report Number
    2015691-2015-00729
    Event Type
    Injury
    Date Received
    March 31, 2015
    Date of Event
    October 31, 2014
    Report Date
    March 3, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT PROVIDED. ADDITIONAL MANUFACTURER NARRATIVE: COMMUNICATION HAS BEEN STARTED WITH THE AUTHOR; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. CASES HAVE BEEN RECEIVED AND REPORTED FOR PATIENTS COVERED BY THIS STUDY. HOWEVER, THERE IS INSUFFICIENT INFORMATION IN THE ARTICLE TO IDENTIFY EACH PATIENT AND LINK TO PREVIOUSLY REPORTED CASES. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ALTHOUGH BIOPROSTHETIC VALVES HAVE BEEN PROVEN TO HAVE EXCELLENT LONG-TERM DURABILITY, FAILURE DOES OCCUR IN A SMALL NUMBER OF VALVES. STRUCTURAL VALVE DETERIORATION (SVD) MAY OCCUR AS A RESULT OF: CALCIFICATION, NON-CALCIFIC DEGENERATION, FIBROSIS OR ENDOCARDITIS. CALCIFICATION CUSP CALCIFICATION, USUALLY PRODUCING STENOSIS, IS CAUSED BY ACCUMULATION OR DEPOSITION OF CALCIUM ON THE VALVE LEAFLETS. CALCIFICATION IS A WELL-RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. 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. NON-CALCIFIC DEGENERATION IS CHARACTERIZED PHYSIOLOGICALLY BY MODERATE TO SEVERE REGURGITATION AND GROSSLY BY PARTIAL TO COMPLETE LOSS OF LEAFLET ARCHITECTURE. IN VITRO AND IN-VIVO TESTING HAVE DEMONSTRATED CONSISTENT PATTERNS OF STRUCTURAL DAMAGE FROM NON-CALCIFIC DEGENERATION, WITH COLLAGEN LOSS WITHIN THE BELLIES OF THE LEAFLETS. THEREFORE, THIS MODE OF FAILURE INCLUDED CUSP TEARS AND PERFORATIONS WITHIN THE BODY OF THE CUSPS THAT WERE UNRELATED TO LEAFLET SEPARATION FROM THE STENT AND DISTINCT FROM TEARS ASSOCIATED WITH CALCIFICATION. FIBROSIS MOST OFTEN RESULTS IN MIXED REGURGITATION AND STENOSIS, WITH THICKENED, STIFF, AND OFTEN FORESHORTENED LEAFLETS, THE EDGES OF WHICH ARE SOMETIMES FUSED. THE FIBROTIC PROCESS MAY BE RESTRICTED TO THE LEAFLETS THEMSELVES; HOWEVER, THE FIBROSIS MAY REPRESENT TISSUE INGROWTH FROM A SOURCE EXTRINSIC TO THE LEAFLETS, SIMILAR TO THAT OF PANNUS FORMATION. PROSTHETIC VALVE ENDOCARDITIS OCCURRING EARLY POST-OPERATIVELY, WITHIN 60 DAYS, IS USUALLY DUE TO PERIOPERATIVE BACTERIAL CONTAMINATION OF THE VALVE. LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION, WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES PRODUCES AND PROVIDES STERILE TISSUE BIOPROSTHESES TO ITS CUSTOMERS BY FOLLOWING CAREFULLY DESIGNED ROBUST STERILIZATION PROCESSES. THESE MANUFACTURING PROCESSES HAVE BEEN VALIDATED AND DEMONSTRATED TO CONSISTENTLY PROVIDE A SIGNIFICANT SAFETY FACTOR FROM WHICH MICROORGANISMS COULD NOT SURVIVE. MICROBIOLOGY AND PROCESS MONITORING IS ROUTINELY REVIEWED WITHIN QUALITY SYSTEMS TO MAINTAIN STERILITY CONTROL. VALIDATED TESTING HAS DEMONSTRATED THAT MICROORGANISMS COULD NOT SURVIVE EDWARDS' MULTI-STAGE PROCESSING WITH ENHANCED STERILANT OR HEATED GLUTARALDEHYDE TERMINAL STERILANT SOLUTION. THESE MULTIPLE, REDUNDANT MANUFACTURING CONTROLS ENSURE THE STERILITY OF EDWARDS' VALVES AS PROVIDED TO CUSTOMERS. THEREFORE, THE PROBABILITY OF ENDOCARDITIS RELATED TO EDWARDS' BIOPROSTHESES IS REMOTE.

    Description of Event or Problem · 1

    ARTICLE: ¿LONG-TERM DURABILITY OF BIOPROSTHETIC AORTIC VALVES: IMPLICATIONS FROM 12,569 IMPLANTS¿ PUBLISHED IN ANNALS OF THORACIC SURGERY 2015, 31 OCT 2014; DOI HTTP://DX.DOI.ORG/10.1016/J.ATHORACSUR.2014.10.070. BACKGROUND. INCREASED LIFE EXPECTANCY AND YOUNGER PATIENTS¿ DESIRE TO AVOID LIFELONG ANTICOAGULATION REQUIRES A BETTER UNDERSTANDING OF BIOPROSTHETIC VALVE FAILURE. THIS STUDY EVALUATES RISK FACTORS ASSOCIATED WITH EXPLANTATION FOR STRUCTURAL VALVE DETERIORATION (SVD) IN A LONG-TERM SERIES OF CARPENTIER-EDWARDS PERIMOUNT AORTIC VALVES (AV). METHODS. FROM (B)(6) 1982 TO (B)(6) 2011, 12,569 PATIENTS UNDERWENT AV REPLACEMENT WITH EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT STENTED BOVINE PERICARDIAL PROSTHESES, MODELS 2700PM (N EQUALS 310) OR 2700 (N EQUALS 12,259). MEAN AGE WAS 71 PLUS/MINUS 11 YEARS (RANGE, 18 TO 98 YEARS). NINETY THREE PERCENT HAD NATIVE AV DISEASE, 48 PERCENT UNDERWENT CONCOMITANT CORONARY ARTERY BYPASS GRAFTING, AND 26 PERCENT HAD ADDITIONAL VALVE SURGERY. THERE WERE 81,706 PATIENT-YEARS OF SYSTEMATIC FOLLOW-UP DATA AVAILABLE FOR ANALYSIS. DEMOGRAPHICS, INTRAOPERATIVE VARIABLES, AND 27,386 ECHOCARDIOGRAPHIC RECORDS WERE USED TO IDENTIFY RISKS FOR EXPLANT FOR SVD AND ASSESS LONGITUDINAL CHANGES IN TRANS-PROSTHESIS GRADIENTS USING TIME-VARYING COVARIABLE ANALYSES. RESULTS. THREE HUNDRED FIFTY-FOUR EXPLANTS WERE PERFORMED, WITH 41 PERCENT RELATED TO ENDOCARDITIS AND 44 PERCENT TO SVD. ACTUARIAL ESTIMATES OF EXPLANT FOR SVD AT 10 AND 20 YEARS WERE 1.9 PERCENT AND 15 PERCENT OVERALL, RESPECTIVELY, AND IN PATIENTS YOUNGER THAN 60 YEARS, 5.6 PERCENT AND 46 PERCENT, RESPECTIVELY. YOUNGER AGE (P WAS LESS THAN 0.0001), LIPID-LOWERING DRUGS (P EQUALS 0.002), PROSTHESIS¿PATIENT MISMATCH (P EQUALS 0.001), AND HIGHER POSTOPERATIVE PEAK AND MEAN AV GRADIENTS WERE ASSOCIATED WITH EXPLANT FOR SVD (P WAS LESS THAN 0.0001). THE EFFECT OF GRADIENT ON SVD WAS GREATEST IN PATIENTS YOUNGER THAN 60 YEARS. CONCLUSIONS. DURABILITY OF THE CARPENTIER-EDWARDS PERIMOUNT AORTIC VALVE IS EXCELLENT EVEN IN YOUNGER PATIENTS. EXPLANT FOR SVD IS RELATED TO GRADIENT AT IMPLANTATION, ESPECIALLY IN YOUNGER PATIENTS. STRATEGIES TO REDUCE EARLY POSTOPERATIVE AV GRADIENTS, SUCH AS ROOT ENLARGEMENT OR MORE EFFICIENT PROSTHESES, SHOULD BE CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210800 CARPENTIER-EDWARDS® PERIMOUNT® AORTIC PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2700

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R