BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 23791197 · Received December 12, 2025

    Report

    Report Number
    2015691-2025-09981
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    November 19, 2025
    Report Date
    January 12, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11. ADDITIONAL NARRATIVE. SURGICAL/PERCUTANEOUS INTERVENTION IS INDICATED OR PERFORMED, OR HARM OCCURRED DUE TO THE DEVICE, OR THERE IS A DEVICE MALFUNCTION THAT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. THIS EVENT IS CONSIDERED A SERIOUS INJURY. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION.

    Additional Manufacturer Narrative · 0

    ENGINEERING EVALUATION SUMMARY: PER DOC-0221939, 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. SVD IS AN ACQUIRED CONDITION, INTRINSIC TO BIOPROSTHETIC VALVES, CHARACTERIZED BY DETERIORATION OF THE LEAFLETS OR SUPPORTING STRUCTURES, LEADING TO THICKENING, CALCIFICATION, TEARING, OR DISRUPTION OF THE PROSTHETIC VALVE MATERIALS. THESE CHANGES RESULT IN VALVULAR DYSFUNCTION MANIFESTING AS STENOSIS AND/OR REGURGITATION WITH A CONSEQUENT DROP IN HEMODYNAMIC EFFICACY OF THE VALVE... 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND NO RELEVANT NON-CONFORMANCES WERE IDENTIFIED. THERE IS NO EVIDENCE TO SUGGEST A MANUFACTURING DEFECT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION AVAILABLE, THE MOST LIKELY ROOT CAUSE IS PATIENT FACTORS, INCLUDING CAD, ATHEROSCLEROSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 23MM RESILIA INSPIRIS AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY 5 YEARS DUE TO SEVERE TORN LEAFLET. THE PATIENT PRESENTED WITH HEART FAILURE SYMPTOMS. TAVR WAS COMPLETED WITH A 23MM 9755RSL TRANSCATHETER VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2710647 EDWARDS INSPIRIS RESILIA AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 11500A23

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H| L