BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 20731564 · Received November 20, 2024

    Report

    Report Number
    2015691-2024-08754
    Event Type
    Injury
    Date Received
    November 20, 2024
    Report Date
    December 26, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED INFORMATION TO SECTION E1 AND H6 (INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS). CORRECTED DATA IN SECTION H6 (TYPE OF INVESTIGATION): THE CODE "4114 - DEVICE NOT RETURNED" WAS REPLACED BY "4117 - DEVICE NOT ACCESSIBLE FOR TESTING." H11. ADDITIONAL NARRATIVE/DATA: THE DEVICE WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR FURTHER INVESTIGATION, AND NO MEDICAL RECORDS OR IMAGES WERE PROVIDED. ATTEMPTS TO RETRIEVE THE DEVICE AND ADDITIONAL INFORMATION WERE UNSUCCESSFUL. CALCIFIC DEGENERATION INVOLVES THE GRADUAL ACCUMULATION OF CALCIUM DEPOSITS ON THE VALVE LEAFLETS. IT IS A DISEASE CONTINUUM FROM SCLEROSIS TO CHRONIC INFLAMMATION THAT LEADS TO LEAFLET CALCIFICATION. THESE CALCIUM DEPOSITS, OVER TIME, CAUSE THE LEAFLETS TO BECOME RIGID AND LESS FLEXIBLE, WHICH CAN ACCOUNT FOR FAILURE MODES SUCH AS STENOSIS AND REGURGITATION. STRUCTURAL VALVE DEGENERATION (SVD) IS A LOGICAL AND EXPECTED CONSEQUENCE OF THE CHEMICAL, MECHANICAL, AND IMMUNOLOGICAL PROCESSES ASSOCIATED WITH BHV IMPLANTATION. THE COMMON ENDPOINT OF ALL THESE FACTORS IS CALCIFICATION AND DEGRADATION. PRIOR INVESTIGATIONS AND EXTENSIVE LITERATURE REVIEW HAVE SHOWN THAT SVD IS PREDOMINANTLY RELATED TO PATIENT FACTORS AND IMPLANT DURATION RATHER THAN TO MANUFACTURING ISSUES. EVENTS RELATED TO DEVICE DESIGN, MANUFACTURING, OR USE ERROR TEND TO MANIFEST AT AN EARLIER IMPLANT DURATION. CALCIFICATION IS MOST COMMONLY RELATED TO PATIENT FACTORS AND IS NOT USUALLY AN INDICATION OF A MANUFACTURING NON-CONFORMANCE. THE INSTRUCTIONS FOR USE (IFU) HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, PATIENT AND/OR PROCEDURAL FACTORS LIKELY CAUSED OR CONTRIBUTED. THERE IS NO EVIDENCE TO SUGGEST AN EDWARDS MANUFACTURING DEFECT.

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS THE DEVICE REQUEST IS ONGOING. 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 · 0

    EDWARDS RECEIVED NOTIFICATION THAT A VALVE MODEL 1150029 WAS EXPLANTED FROM A 63-YEAR-OLD PATIENT AFTER AN IMPLANT DURATION OF APPROXIMATELY FOUR (4) YEARS DUE TO CALCIFICATION. A MECHANICAL VALVE WAS IMPLANTED IN REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938756 EDWARDS INSPIRIS RESILIA AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 11500A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Life Threatening| R| H