BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 8511900 · Received April 12, 2019

    Report

    Report Number
    2015691-2019-01306
    Event Type
    Injury
    Date Received
    April 12, 2019
    Date of Event
    March 20, 2019
    Report Date
    March 20, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL MANUFACTURER NARRATIVE: EDWARDS RECEIVED ADDITIONAL INFORMATION THROUGH FOLLOW UP WITH THE HEALTHCARE PROVIDER. SUPPLEMENTAL REPORT SUBMITTED TO INCLUDE ADDITIONAL INFORMATION RECEIVED. UPDATED B5, B7, AND F10.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE:SUPPLEMENTAL REPORT SUBMITTED TO INCLUDE ADDITIONAL INFORMATION RECEIVED. UPDATED B5.

    Description of Event or Problem · 0

    EDWARDS RECEIVED ADDITIONAL INFORMATION THROUGH FOLLOW UP WITH THE HEALTHCARE PROVIDER. IT WAS REPORTED A 19MM AORTIC VALVE IMPLANTED FOR 12 YEARS 9 MONTHS, WAS DISABLED VIA A VALVE IN VALVE PROCEDURE DUE TO SEVERE STENOSIS AND REGURGITATION. A 20MM TRANSCATHETER VALVE WAS IMPLANTED. THE PATIENT IS REPORTED TO BE WELL AND IN STABLE CONDITION POST PROCEDURE. THERE WAS NO PREMATURE FAILURE OF THE DEVICE REPORTED. THE PATIENT WAS DISCHARGED IN STABLE CONDITION ON POST-OPERATIVE DAY ONE.

    Description of Event or Problem · 0

    EDWARDS RECEIVED ADDITIONAL INFORMATION THROUGH FOLLOW UP WITH THE HEALTHCARE PROVIDER. IT WAS REPORTED THAT A 19MM AORTIC VALVE IMPLANTED FOR 12 YEARS 9 MONTHS, WAS DISABLED VIA A VALVE IN VALVE PROCEDURE DUE TO STENOSIS AND REGURGITATION. A 20MM TRANSCATHETER VALVE WAS IMPLANTED. THE PATIENT IS REPORTED TO BE WELL AND IN STABLE CONDITION POST PROCEDURE. NO PREMATURE FAILURE OF THE DEVICE WAS REPORTED.

    Additional Manufacturer Narrative · 1

    BIOPROSTHETIC VALVES ARE KNOWN TO HAVE A LIMITED LIFE SPAN AS THE SURGICAL PROSTHESIS IS PRONE TO STRUCTURAL VALVE DEGENERATION (SVD) DUE TO A GRADUAL, MULTI-YEAR PROCESS OF CALCIFICATION OF THE LEAFLETS RESULTING FROM THE PRE-EXISTING DISEASE PROCESS. IT MAY PRESENT AS REGURGITATION AND/OR STENOSIS. THIS IS AN EXPECTED AND FORESEEABLE RESULT IN VALVES THAT HAVE BEEN IMPLANTED LONG TERM. SVD IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANTS 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. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR REGURGITATION AND/OR STENOSIS. THE REPORTED EVENT CANNOT BE CONFIRMED SINCE THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. HOWEVER, THIS EVENT MOST LIKELY IMPACTED BY THE PROGRESSION OF THE PATIENT¿S UNDERLYING VALVULAR DISEASE PATHOLOGY WITH OR WITHOUT SVD AND/OR NSVD. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. THERE WERE NO ISSUES IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS. IF ANY NEW INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT IMPLANTED WITH A 19MM 2800 AORTIC VALVE FOR 12 YEARS AND 9 MONTHS, IS BEING CONSIDERED FOR A VALVE-IN-VALVE PROCEDURE DUE TO AORTIC STENOSIS. THE PATIENT HAS NOT BEEN SCHEDULED FOR A PROCEDURE TO DATE. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300655 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other