BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 20973023 · Received December 18, 2024

    Report

    Report Number
    2015691-2024-09775
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    November 25, 2024
    Report Date
    February 3, 2025
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    LWR
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS: B4, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). 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. ENGINEERING EVALUATION SUMMARY: PER TECHNICAL SUMMARY DOC-0221939, REV B, CALCIFIC DEGENERATION INVOLVES THE GRADUAL ACCUMULATION OF CALCIUM DEPOSITS ON THE VALVE LEAFLETS. IT IS A DISEASE CONTINUUM FROM SCLEROSIS TO CHRONIC INFLAMMATION THAT LEADS TO LEAFLET CALCIFICATION. THESE CALCIUM DEPOSITS, OVER TIME, CAUSE THE LEAFLETS TO BECOME RIGID AND LESS FLEXIBLE, WHICH CAN ACCOUNT FOR FAILURE MODES SUCH AS STENOSIS AND REGURGITATION. 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. 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. THE INSTRUCTIONS FOR USE (IFU) HAVE BEEN REVIEWED, AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARD TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. THE REPORTED TYPE OF EVENT IS INCLUDED IN THE IFU. A DHR REVIEW WAS PERFORMED, AND NO RELATED MANUFACTURING NONCONFORMANCES WERE IDENTIFIED. 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 USE-RELATED ISSUE WITH A HAZARDOUS SITUATION; NO DEVICE-RELATED INFECTION; AND NO EVIDENCE OF A PRODUCT FAILURE WITH REGARD TO DESIGN, RELIABILITY, OR USE ERROR. PER DOC-0101337, REV Q, AND DOC-0076862, REV O, A CAPA/SCAR/PRA IS NOT REQUIRED, AS THERE ARE NO CONFIRMED PRODUCT OR LABELING NON-CONFORMANCES AND NO OTHER TRIGGERS ARE MET. A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, PATIENT AND/OR PROCEDURAL FACTORS LIKELY CAUSED OR CONTRIBUTED.

    Additional Manufacturer Narrative · 0

    H11: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A 29MM 11500A AORTIC VALVE IN AORTIC POSITION IS UNDER EVALUATION FOR A POSSIBLE VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 8 MOTHS DUE TO CALCIFICATION. TAVR HAS NOT BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024136 EDWARDS INSPIRIS RESILIA AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES LLC 11500A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Other| L