BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 12537504 · Received September 27, 2021

    Report

    Report Number
    2015691-2021-05382
    Event Type
    Injury
    Date Received
    September 27, 2021
    Date of Event
    September 2, 2021
    Report Date
    January 8, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: A4, B1, B2, B5, B6, H1, H6 HEALTH EFFECT - IMPACT CODE, DEVICE CODE(S), AND TYPE OF INVESTIGATION. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 0

    UPDATED SECTION H6 TYPE OF INVESTIGATION AND INVESTIGATION CONCLUSIONS. TISSUE DEGENERATION-RELATED STRUCTURAL DETERIORATION, EITHER CALCIFIC OR NON-CALCIFIC, ARE COMMON CHRONIC FAILURE MODES FOR THIS TYPE OF BIOPROSTHETIC HEART VALVE. OPERATIONAL MECHANICAL STRESS AND BIOLOGICAL FACTORS ARE GENERALLY BELIEVED TO BE THE MAJOR CONTRIBUTORS TO THE NON-CALCIFIC BIOPROSTHETIC TISSUE DEGENERATION. STRUCTURAL VALVE DETERIORATION (SVD) CAN, AND TYPICALLY DOES, LEAD TO CHRONIC CENTRAL LEAKS OVER A PERIOD OF TIME. SVD IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANT AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NONCALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. THROUGH FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE ROOT CAUSE OF THIS EVENT IS INCONCLUSIVE.

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: D4 EXPIRATION DATE, H4, H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWS THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THROUGH FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE ROOT CAUSE OF THIS EVENT IS INCONCLUSIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A 27MM 6900PTFX MITRAL VALVE IMPLANTED FOR 6 YEAR AND 3 MONTHS, UNDERWENT REDO MITRAL VALVE REPLACEMENT DUE TO TWO OF THREE LEAFLETS THICKENED AND SEVERELY RESTRICTED IN MOTION WITH SEVERE STENOSIS AND MINIMAL REGURGITATION. A 29MM 7300TFX AORTIC VALVE WAS IMPLANTED IN REPLACEMENT.

    Additional Manufacturer Narrative · 1

    STENOSIS, WHICH DEVELOPS PROGRESSIVELY OVER TIME, CAN BE DUE TO A NUMBER OF ISSUES. ADDITIONALLY, THERE CAN BE A NUMBER OF POTENTIAL KNOWN AND UNKNOWN PATIENT RELATED CONTRIBUTING FACTORS. STRUCTURAL VALVE DETERIORATION (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, MAY CONTRIBUTE TO STENOSIS AND/OR REGURGITATION. ALTERNATIVELY, THE NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR STENOSIS. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED. ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH A 27 MM 6900PTFX MITRAL VALVE IMPLANTED FOR 6 YEAR AND 3 MONTHS, IS BEING EVALUATED FOR A VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430277 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX27 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention| H| L