BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 22842290 · Received August 19, 2025

    Report

    Report Number
    2015691-2025-06809
    Event Type
    Injury
    Date Received
    August 19, 2025
    Date of Event
    July 30, 2025
    Report Date
    September 19, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    UDI-DI
    00690103194999
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: G3, G6, H2, H6: (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). REGURGITATION IS A COMMON MANIFESTATION OF BIOPROSTHETIC VALVE AND VALVED CONDUIT DYSFUNCTION. COMMON INTRAOPERATIVE FACTORS THAT MAY CAUSE OR CONTRIBUTE TO ACUTE POST-PROCEDURAL REGURGITATION INCLUDE DEVICE DISTORTION; DEVICE INTERACTION WITH PATIENT ANATOMY OR OTHER DEVICES; LEAFLET DAMAGE, AND INCORRECTLY SIZED VALVE SEATED. NON-STRUCTURAL VALVE DYSFUNCTION (NSVD), ENDOCARDITIS AND/OR THROMBOSIS MAY ALSO CAUSE OR CONTRIBUTE TO ACUTE POST-PROCEDURAL REGURGITATION. COMPLAINTS REPORTED WITH REGURGITATION AS THE PRIMARY COMPLAINT CODE ARE NOT TYPICALLY ATTRIBUTED TO MANUFACTURING-RELATED NONCONFORMANCES. 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 SMOKING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A 25MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 3 YEARS, 11 MONTHS DUE TO SEVERE REGURGITATION AND STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE NYHA 2-3. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9750TFX VALVE. THE PATIENT WAS TRANSFERRED TO CARDIAC UNIT AND DISCHARGED ON POD #1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1282745 EDWARDS INSPIRIS RESILIA AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 11500A 00690103194999

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Hospitalization| R| L