BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 22768106 · Received August 10, 2025

    Report

    Report Number
    2015691-2025-06507
    Event Type
    Injury
    Date Received
    August 10, 2025
    Date of Event
    May 20, 2025
    Report Date
    September 24, 2025
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    LWR
    UDI-DI
    00690103194982
    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: UPDATED SECTIONS: B4, G3, G6, H2, H6 (INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT PERFORMED, AS NO INFORMATION REGARDING A DEVICE FAILURE MODE WAS PROVIDED. FURTHERMORE, THERE IS NO ALLEGATION OF A MALFUNCTION WHICH COULD BE RELATED TO A MANUFACTURING NON-CONFORMANCE AND/OR ONE WAS NOT SUSPECTED OR CONFIRMED THROUGH INVESTIGATION; NO LABELING NON-CONFORMANCE/DEFICIENCY; NO DEVICE-RELATED INFECTION; AND NO EVIDENCE OF A PRODUCT FAILURE WITH REGARD TO DESIGN, RELIABILITY, OR USE ERROR (B)(4). ENGINEERING EVALUATION SUMMARY: THERE IS NO EVIDENCE TO SUGGEST A MANUFACTURING DEFECT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED.

    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.

    Description of Event or Problem · 0

    IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 23MM 11500A RESILIA AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 21MM 11500A RESILIA VALVE AFTER AN IMPLANT DURATION OF 6 YEARS, 2 MONTHS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2003697 EDWARDS INSPIRIS RESILIA AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES LLC 11500A N/A 00690103194982

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention| L| H