BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEE H10

    MDR report key: 3945576 · Received July 21, 2014

    Report

    Report Number
    2015691-2014-01643
    Event Type
    Death
    Date Received
    July 21, 2014
    Date of Event
    December 31, 2011
    Report Date
    June 25, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MODEL IS ONLY KNOWN AS CARPENTIER-EDWARDS PERIMOUNT. SPECIFIC MODEL, SIZE AND SERIAL NUMBER REMAIN UNKNOWN. PMA NUMBER IS UNKNOWN. DEVICE NOT RETURNED. WITHIN THE CONTEXT OF THE ARTICLE, THE FOLLOWING EVENTS WERE IDENTIFIED AS DEVICE RELATED: 4 DEATHS IDENTIFIED AS DUE TO STRUCTURAL VALVE DETERIORATION (SVD); 23 DEATHS IDENTIFIED DUE TO SUDDEN DEATHS AND VALVE-RELATED DEATHS; 63 SVD THAT LEAD TO RE-OPERATION; 1 AORTIC REGURGITATION DETECTED INTRAOPERATIVELY; AND 6 DEHISCED VALVES. ATTEMPTS HAVE BEEN MADE TO GET ADDITIONAL INFORMATION. HOWEVER, NO PATIENT SPECIFIC INFORMATION HAS BEEN MADE AVAILABLE. NO DEVICES HAVE BEEN RETURNED FOR RETURN AND EVALUATION. THEREFORE, THE DEVICE HISTORY RECORD (DHR) REVIEWS CAN NOT BE DONE DUE TO LACK OF MODEL, SIZE AND SERIAL NUMBER OF EACH DEVICE. 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: CUSP CALCIFICATION, USUALLY PRODUCING STENOSIS, IS CAUSED BY ACCUMULATION OR DEPOSITION OF CALCIUM ON THE VALVE LEAFLETS. · 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. · DEHISCENCE MAY OCCUR WHEN LEAFLETS PULL AWAY FROM THE STENT AT THE POINT OF ATTACHMENT, EITHER ALONG THE BASE OF THE CUSP OR AT THE POSTS. THE LOCATION OF THESE TEARS DIFFERENTIATES THIS MODE OF FAILURE FROM NON-CALCIFIC DEGENERATION. DEHISCENCE USUALLY PRODUCES AORTIC REGURGITATION. · FIBROSIS MOST OFTEN RESULTS IN MIXED AORTIC 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.

    Description of Event or Problem · 1

    ARTICLE: ¿VERY LATE OUTCOMES FOR MITRAL VALVE REPLACEMENT WITH THE CARPENTIER-EDWARDS PERICARDIAL BIOPROSTHESIS: 25-YEAR FOLLOW-UP OF 450 IMPLANTATIONS¿ PUBLISHED IN THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, 14 FEBRUARY 2014, DOI: 10.1016/J.JTCVS.2014.02.050. ABSTRACT: FROM 1984 TO 2011, 450 CE PERIMOUNT PERICARDIAL MITRAL BIOPROSTHESES WERE IMPLANTED IN 404 CONSECUTIVE PATIENTS. WITH A LOW RATE OF VALVE-RELATED EVENTS AT 20 YEARS, THE CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS REMAINS A RELIABLE CHOICE FOR A MITRAL TISSUE VALVE, ESPECIALLY IN PATIENTS OVER 60 YEARS OF AGE. OBJECTIVE: THE AIM OF THE STUDY WAS TO EVALUATE THE VERY LONG-TERM RESULTS OF THE CARPENTIER-EDWARDS PERICARDIAL BIOPROSTHESIS IN MITRAL POSITION. METHODS: FROM 1984 TO 2011, 450 CE PERIMOUNT PERICARDIAL MITRAL BIOPROSTHESES WERE IMPLANTED IN 404 CONSECUTIVE PATIENTS (MEAN AGE 68 YEARS, 53 PERCENT FEMALE). PATIENTS UNDERGOING MULTIPLE VALVE REPLACEMENT WERE EXCLUDED. THE CLINICAL, OPERATIVE, AND FOLLOW-UP DATA WERE PROSPECTIVELY RECORDED. THE MEAN FOLLOW-UP WAS 7.2 PLUS/MINUS 5.1 YEARS FOR A TOTAL OF 3,258 VALVE-YEARS. FOLLOW-UP WAS 97.8 PERCENT COMPLETE. RESULTS: OPERATIVE MORTALITY RATE WAS 3.3 PERCENT. THERE WERE 188 LATE DEATHS FOR A LINEARIZED RATE OF 5.8 PERCENT / VALVE-YEAR. AT 20 YEARS, THE OVERALL ACTUARIAL SURVIVAL RATE WAS 16.9 PLUS/MINUS 3.9 PERCENT. AGE AT IMPLANT, PREOPERATIVE NYHA CLASS III OR IV, AND REDO PROCEDURE WERE SIGNIFICANT RISK FACTORS AFFECTING LATE SURVIVAL. ACTUARIAL FREEDOM FROM COMPLICATIONS AT 20 YEARS WAS AS FOLLOWS: THROMBOEMBOLISM 83.9 PLUS/MINUS 7.6 PERCENT; HEMORRHAGE 80.2 PERCENT PLUS/MINUS 10.8 PERCENT; ENDOCARDITIS 94.8 (PLUS/MINUS) 1.4 PERCENT, STRUCTURAL VALVE DETERIORATION 23.7 PLUS/MINUS 6.9 PERCENT, EXPLANT DUE TO STRUCTURAL VALVE DETERIORATION 40.5 PLUS/MINUS 8.0 PERCENT. COMPETING RISK ANALYSIS DEMONSTRATED AN ACTUAL RISK OF EXPLANT DUE TO STRUCTURAL VALVE DETERIORATION AT 20 YEARS OF 25.5 PLUS/MINUS 2.9 PERCENT. THE EXPECTED VALVE DURABILITY WAS 16.6 YEARS FOR THE ENTIRE COHORT (11.4, 16.6 AND 19.4 YEARS FOR THE PATIENTS BELOW 60 YEARS OLD, BETWEEN 60 AND 70, AND ABOVE 70 RESPECTIVELY). CONCLUSIONS: WITH A LOW RATE OF VALVE-RELATED EVENTS AT 20 YEARS AND PARTICULARLY A LOW RATE OF STRUCTURAL VALVE DETERIORATION, THE CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS REMAINS A RELIABLE CHOICE FOR A MITRAL TISSUE VALVE, ESPECIALLY IN PATIENTS OVER 60 YEARS OF AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424409 SEE H10 HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| O| R