BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 23183144 · Received September 30, 2025

    Report

    Report Number
    2015691-2025-07996
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    June 24, 2025
    Report Date
    November 21, 2025
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    LWR
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS: B4, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). 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 HLD AND CHEMOTHERAPY/RADIOTHERAPY.

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS: B4, B5, B7, G3, G6, H2, H6 (COMPONENT CODE, CLINICAL CODES, AND DEVICE CODE).

    Description of Event or Problem · 0

    IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 8300AB AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 27MM 11500A INSPIRIS RESILIA AORTIC VALVE AFTER AN IMPLANT DURATION OF 6 YEARS, AND 11 MONTHS. PATIENT WAS IN RECOVERY POST-PROCEDURE. REASON FOR REINTERVENTION WAS NOT PROVIDED. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

    Description of Event or Problem · 0

    IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 25MM 8300AB AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 27MM 11500A INSPIRIS RESILIA AORTIC VALVE AFTER AN IMPLANT DURATION OF 6 YEARS, AND 11 MONTHS DUE TO CALCIFICATION WITH STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE, AND SHORTNESS OF BREATH. REPORTEDLY, PATIENT WAS IN RECOVERY POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659017 EDWARDS INSPIRIS RESILIA AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES LLC 8300AB N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Hospitalization| R| L