BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 22637711 · Received July 28, 2025

    Report

    Report Number
    2015691-2025-06123
    Event Type
    Injury
    Date Received
    July 28, 2025
    Date of Event
    July 3, 2025
    Report Date
    August 22, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    UDI-DI
    00690103194975
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: 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

    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 ROOT CAUSE REMAINS INDETERMINABLE AS NO PATIENT OR PROCEDURAL FACTORS KNOWN TO CAUSE OR CONTRIBUTE TO SVD WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A 21MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 11 MONTHS DUE TO CALCIFICATION. THE TAVR WAS PERFORMED WITH A 23MM 9755RSL VALVE. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611099 EDWARDS INSPIRIS RESILIA AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 11500A 00690103194975

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Hospitalization| R| L