BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 22498173 · Received July 14, 2025

    Report

    Report Number
    2015691-2025-05696
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    June 23, 2025
    Report Date
    August 19, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    UDI-DI
    00690103194968
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 H6 (INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). BASED ON THE INFORMATION AVAILABLE, THE DEVICE WAS INTENTIONALLY USED OUTSIDE THE WAY IT WAS DESIGNED AND INTENDED. THE PERFORMANCE, SAFETY, EFFICACY, LONGEVITY, AND DURABILITY OF BIOPROSTHETIC VALVES HAVE NOT BEEN DETERMINED WHEN THE PRODUCT IS USED OUTSIDE THE SCOPE OF ITS INTENDED USE AND/OR ITS STUDIED POPULATION. REGURGITATION IDENTIFIED POST-PROCEDURALLY HAS MANY POTENTIAL ROOT CAUSES, INCLUDING STRUCTURAL VALVE DETERIORATION (SVD), NON-STRUCTURAL VALVE DYSFUNCTION (NSVD), ENDOCARDITIS AND/OR THROMBOSIS. REGURGITATION OCCURRING POST-PROCEDURALLY IS MOST COMMONLY RELATED TO PATIENT AND/OR PROCEDURAL FACTORS AND IS NOT TYPICALLY AN INDICATION OF A DEVICE MALFUNCTION RELATED TO A MANUFACTURING NON-CONFORMANCE. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. 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. THERE IS INSUFFICIENT INFORMATION AVAILABLE REGARDING PATIENT OR PROCEDURAL FACTORS KNOWN TO CAUSE OR CONTRIBUTE TO REGURGITATION. THEREFORE, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. 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. H11: CORRECTED DATA: CORRECTED SECTION H6 (TYPE OF INVESTIGATION).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A 19MM 11500A AORTIC VALVE, IMPLANTED IN THE PULMONARY POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 3 YEARS, 5 MONTHS DUE TO REGURGITATION AND STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 23MM 9600TFX TRANSCATHETER VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302314 EDWARDS INSPIRIS RESILIA AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 11500A 00690103194968

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention| L| H