BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 8593457 · Received May 8, 2019

    Report

    Report Number
    2015691-2019-01641
    Event Type
    Injury
    Date Received
    May 8, 2019
    Date of Event
    April 13, 2019
    Report Date
    April 13, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 UPDATE B5, B7, AND F10. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE EVENT WAS LIKELY DUE TO PATIENT RELATED FACTORS AND THE PROGRESSION OF THE PATIENT'S UNDERLYING VALVULAR DISEASE PATHOLOGY.

    Additional Manufacturer Narrative · 0

    EDWARDS RECEIVED ADDITIONAL INFORMATION THROUGH FOLLOW UP WITH THE HEALTHCARE PROVIDER. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE EVENT REMAINS INDETERMINABLE. HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE PATIENT'S UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    EDWARDS RECEIVED ADDITIONAL INFORMATION THROUGH FOLLOW UP WITH THE HEALTHCARE PROVIDER. IT WAS REPORTED A PATIENT INITIALLY IMPLANTED WITH A 23MM FOR 11 YEARS 6 MONTHS WAS EXPLANTED AND REPLACED WITH A 21MM EDWARDS VALVE DUE TO SEVERE STENOSIS WITH ELEVATED VELOCITIES ACROSS THE VALVE. THE PATIENT WAS NOTED TO BE DOING WELL WAS DISCHARGED ON POST-OPERATIVE DAY SIX.

    Description of Event or Problem · 0

    EDWARDS RECEIVED ADDITIONAL INFORMATION THROUGH FOLLOW UP THAT THE 23MM PERICARDIAL AORTIC VALVE IMPLANTED FOR 11 YEARS 6 MONTH WAS EXPLANTED AND REPLACED WITH A 21MM EDWARDS VALVE DUE TO ELEVATED VELOCITIES ACROSS THE VALVE. THE PATIENT WAS NOTED TO BE DOING WELL.

    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/REPLACEMENTS 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. REQUESTS FOR ADDITIONAL INFORMATION ARE CURRENTLY IN PROGRESS. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED AT THIS TIME. IF ANY NEW INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT IMPLANTED WITH A 23MM 3000TFX VALVE FOR 11 YEARS AND 6 MONTHS, IS PENDING A VALVE-IN-VALVE PROCEDURE. THE REASON FOR THE VALVE REPLACEMENT IS UNKNOWN. THE PROCEDURE HAS NOT BEEN SCHEDULED AT THIS TIME. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386942 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-07H1654

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other