BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL MITRAL BIOPROSTHESIS

    MDR report key: 5565329 · Received April 8, 2016

    Report

    Report Number
    2015691-2016-01157
    Event Type
    Injury
    Date Received
    April 8, 2016
    Date of Event
    March 14, 2016
    Report Date
    March 14, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE - THE REPORTED DEVICE WAS NOT RETURNED TO MANUFACTURER. WITHOUT RETURN OF THE EXPLANTED DEVICE THE REPORTED CLINICAL OBSERVATION CANNOT BE CONFIRMED. REGURGITATION IS CONSIDERED TO BE A PERIVALVULAR LEAK (PVL) IF A TURBULENT ECCENTRIC JET ORIGINATES BETWEEN THE BIOPROSTHETIC SEWING RING AND THE ANNULUS. WHILE THE MAJORITY OF AFFECTED PATIENTS ARE ASYMPTOMATIC, PVL CAN OCCUR IN THE MITRAL AND AORTIC POSITION FOR SIMILAR REASONS, INCLUDING TECHNIQUE AND PATIENT RELATED FACTORS. NO CAPA IS APPLICABLE; HOWEVER, 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

    ARTICLE ¿MECHANICAL PROSTHESIS IS REASONABLE FOR MITRAL VALVE REPLACEMENT IN PATIENTS APPROXIMATELY 65 YEARS OF AGE¿ (ANN THORAC SURG 2013;96:1614¿20) PUBLISHED IN 2013 BY THE SOCIETY OF THORACIC SURGEONS THE LONG-TERM RESULTS OF MITRAL VALVE REPLACEMENT (MVR; N [ 631) WITH A BILEAFLET MECHANICAL PROSTHESIS OR A CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS WERE EVALUATED IN (B)(6) PATIENTS OF DIFFERENT AGE GROUPS. A TOTAL OF 507 BILEAFLET MECHANICAL PROSTHESES AND 124 BIOPROSTHESES HAVE BEEN IMPLANTED SINCE 1982 AT OUR INSTITUTION. FOLLOW-UP WAS COMPLETED FOR 6,598 PATIENT-YEARS IN 98.4% OF THE CASES. AMONG THE PATIENTS 70 YEARS OF AGE AND OLDER, THE RATE OF FREEDOM FROM VALVE-RELATED DEATH AND VALVE RELATED MORBIDITY AT 10 YEARS AFTER SURGERY WERE SIGNIFICANTLY BETTER IN THE BIOPROSTHESES GROUP (93.3% ± 6.4% AND 83.7% ± 8.7%, RESPECTIVELY; N[35) THAN IN THE MECHANICAL PROSTHESES GROUP (71.1% ± 8.0% AND 60.9% ± 8.9%, RESPECTIVELY; N [ 82), AND NEITHER STRUCTURAL VALVE DETERIORATION (SVD) NOR RESULTING RE-MVR WERE OBSERVED FOR BIOPROSTHESES. IN CONTRAST, AMONG THE PATIENTS 64 YEARS AND YOUNGER, NO SIGNIFICANT DIFFERENCES WERE OBSERVED IN LONG-TERM SURVIVAL BETWEEN THE MECHANICAL PROSTHESES GROUP (N [ 347) AND THE BIOPROSTHESES GROUP (N [ 76), WHILE SIGNIFICANTLY LOWER RATES OF FREEDOM FROM SVD AND RE-MVR WERE OBSERVED IN THE BIOPROSTHESES GROUP COMPARED WITH THOSE OBTAINED IN THE MECHANICAL PROSTHESES GROUP. AS FOR THE CONTROVERSIAL INTERMEDIATE-AGE GROUP OF 65 TO 69 YEARS, THE GENERAL TENDENCIES WERE SIMILAR TO THOSE OBSERVED IN THE GROUP 64 YEARS AND YOUNGER. BASED ON OUR COMPARATIVE EVALUATION, BIOPROSTHESES SHOULD BE CHOSEN FOR MVR IN PATIENTS 70 YEARS OF AGE AND OLDER, WHEREAS MECHANICAL PROSTHESES WERE BETTER IN THE PATIENTS 64 YEARS OF AGE AND YOUNGER. THE USE OF BIOPROSTHESES IN (B)(6) PATIENTS 65 TO 69 YEARS OF AGE IS NOT PREFERABLE FOR PREVENTING SVD AND SUBSEQUENT RE-MVR. OCCURENCE DATE, VALVE SIZE AND SERIAL NUMBER FOR EACH CASES WERE UNKNOWN. INFORMATION FOR PRODUCT RETURN WAS NOT PROVIDED BY THE CUSTOMER,THEREFORE, NO DEVICE WAS RETURNED FOR EVALUATION. IN THE CONTEXT OF THIS ARTICLE ONE (1) CASE OF PARAVALVULAR LEAKAGE WAS OBSERVED IN THE BIOPROSTHESIS GROUP IN A PATIENT AGED 64 YEARS AND YOUNGER. THERE IS INDICATION THAT DEVICE MAY HAVE BEEN EXPLANTED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217991 CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL MITRAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S