BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 23341822 · Received October 20, 2025

    Report

    Report Number
    2015691-2025-08664
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    September 18, 2025
    Report Date
    November 25, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    UDI-DI
    00690103194975
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS G3, G6, H2. H11: CORRECTED DATA: CORRECTED SECTIONS B5, H6 (CLINICAL CODE).

    Additional Manufacturer Narrative · 0

    H11: CORRECTED DATA: H6 (TYPE OF INVESTIGATION). H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). 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. 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN PRODUCT FOR EVALUATION. NO DEVICE WAS RETURNED. 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. THE REPORTED TYPE OF EVENT IS INCLUDED IN THE IFU. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. THERE WERE NO ISSUES IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 9 MONTHS DUE TO SEVERE AORTIC STENOSIS AND LEAFLET CALCIFICATION. THE PATIENT PRESENTED WITH FATIGUE AND SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. PER THE RECORDS PROVIDED, THE PATIENT UNDERWENT AVR WITH A 21MM VALVE AND DID WELL AFTER SURGERY; HOWEVER, AFTER SOME TIME STARTED FEELING TIRED, FATIGUED AND SHORT OF BREATH, THE PATIENT WAS SEEN BY DR. KIM AND WAS FOUND TO HAVE PROGRESSED TO MODERATE TO SEVERE STENOSIS AND WERE SENT TO EVALUATION FOR A POSSIBLE SURGERY. DURING SURGERY THE AORTA WAS OPENED THEY SAW THE PERICARDIAL TISSUE VALVE WITH SOME CALCIFICATIONS. THE SUTURES AROUND THE VALVE WERE CUT AND RESECTED. THE ANNULUS WAS DEBRIDED OF ANY CALCIUM AND A 23MM 11500A VALVE WAS IMPLANTED. THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION. THERE WERE NO COMPLICATIONS. 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 MEDICAL RECORDS THAT A PATIENT WITH A 21MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 9 MONTHS DUE TO LEAFLET CALCIFICATION AND SEVERE AORTIC STENOSIS. THE PATIENT PRESENTED WITH FATIGUE AND SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. PER THE RECORDS, THE PATIENT PRESENTED WITH SIGNS AND SYMPTOMS OF CLASS II NYHA CHF INCLUDING DOE AND INCREASING FATIGUE. WORKUP REVEALED MODERATE TO SEVERE STENOSIS REQUIRING EVALUATION FOR A POSSIBLE INTERVENTION. THE PATIENT UNDERWENT AVR UTILIZING A 23MM 11500A INSPIRIS RESILIA AORTIC VALVE. DURING THE PROCEDURE THE AORTA WAS OPENED AND CALCIFICATIONS WERE SEEN ON THE PREVIOUSLY IMPLANTED VALVE. THE SUTURES AROUND THE VALVE WERE CUT AND THE IMPLANTED DEVICE WAS REMOVED. THE ANNULUS WAS DEBRIDED OF ANY CALCIUM AND A 23MM 11500A VALVE WAS IMPLANTED. THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION. THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2284237 EDWARDS INSPIRIS RESILIA AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 11500A 00690103194975

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Hospitalization| R| L