BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 22665740 · Received July 30, 2025

    Report

    Report Number
    2015691-2025-06171
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    July 7, 2025
    Report Date
    August 20, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    UDI-DI
    00690103194982
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE: THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT. 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

    H10: ADDITIONAL MANUFACTURER NARRATIVE: . H11: CORRECTIVE DATA: BASED ON THE ADDITIONAL INFORMATION OBTAINED, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE AND THIS CORRECTION IS BEING SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A 23MM 11500A AORTIC VALVE HAS BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 1 YEAR, 10 MONTHS DUE TO AORTIC STENOSIS. NO PLANNED PROCEDURE AT THIS TIME AS THE PATIENT MAY NEED FURTHER TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A 23MM 11500A AORTIC VALVE HAS BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 1 YEAR,10 MONTHS DUE TO SUSPECTED SUBCLINICAL LEAFLETS THROMBOSIS (HALT). CARDIAC WORKUP REVEALED HIGH GRADIENT ACROSS THE BIOPROSTHETIC VALVE. THE PATIENT WAS PLACED ON ORAL ANTICOAGULANT WITH NO PLAN FOR INTERVENTION AT THIS TIME. THE PATIENT WILL FOLLOW-UP WITH THE PHYSICIAN IN 6 MONTHS WITH TRANSTHORACIC ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46882 EDWARDS INSPIRIS RESILIA AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 11500A NA 00690103194982

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Life Threatening