BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    HEART-VALVE, NON-ALLOGRAFT TISSUE

    MDR report key: 24984200 · Received April 24, 2026

    Report

    Report Number
    2015691-2026-14660
    Event Type
    Injury
    Date Received
    April 24, 2026
    Report Date
    April 24, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11. CORRECTED DATA: ATTACHED THE EVENT SPECIFIC INFORMATION .CSV FILE THAT WAS MISSING IN THE INITIAL SUBMISSION.

    Additional Manufacturer Narrative · 0

    H11. ADDITIONAL NARRATIVE: THIS REPORT SUMMARIZES 31 VALVE IN VALVE ADVERSE EVENTS THAT WOULD HAVE BEEN REPORTED TO THE FDA BETWEEN JANUARY 1 AND MARCH 31, 2026, FOR PRODUCT CODE LWR. 30 EVENTS WERE IDENTIFIED THROUGH EXTERNAL SOURCES AND ONE EVENT WAS IDENTIFIED THROUGH EDWARDS INTERNAL IMPLANT REGISTRY. THE TOTAL NUMBER OF PATIENTS WITHIN EVENTS IDENTIFIED THROUGH THE INTERNAL IMPLANT REGISTRY WAS 1. THE SUBJECT DEVICES WERE NOT AVAILABLE FOR EVALUATION, AS THEY REMAINED IMPLANTED. BASED ON THE INVESTIGATION RESULTS COMPLETED AT THE TIME OF THIS REPORT SUBMISSION, AN EDWARDS MANUFACTURING DEFECT WAS NOT CONFIRMED AS THE ROOT CAUSE OF ANY EVENTS. NO NEW RISKS OR UNEXPECTED FAILURE MODES WERE IDENTIFIED. ROUTINE MONITORING AND TRENDING ACTIVITIES REMAIN IN PLACE, AND NO ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 31 VALVE-IN-VALVE ADVERSE EVENTS THAT WOULD HAVE BEEN REPORTED TO THE FDA BETWEEN (B)(6) 2026 FOR PRODUCT CODE LWR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039195 HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES PRODUCT CODE LWR

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Required Intervention