BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    HEART-VALVE, NON-ALLOGRAFT TISSUE

    MDR report key: 24222914 · Received January 30, 2026

    Report

    Report Number
    2015691-2026-10682
    Event Type
    Injury
    Date Received
    January 30, 2026
    Report Date
    April 30, 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. ADDITIONAL NARRATIVE THIS REPORT SUMMARIZES 14 VALVE-IN-VALVE ADVERSE EVENTS THAT WOULD HAVE BEEN REPORTED TO THE FDA BETWEEN OCTOBER 1 AND DECEMBER 31, 2025, FOR PRODUCT CODE LWR. 13 EVENTS WERE IDENTIFIED THROUGH EXTERNAL SOURCES AND 1 EVENT WAS IDENTIFIED THROUGH EDWARDS INTERNAL IMPLANT REGISTRY. THE TOTAL NUMBER OF PATIENTS WITHIN EVENTS IDENTIFIED THROUGH EXTERNAL SOURCES WAS 13, AND 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.

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL NARRATIVE ADDED EXEMPTION NUMBER "GEN2400831" WHICH WAS MISSING IN THE INITIAL REPORT. UPDATED THE EVENT SPECIFIC INFORMATION FILE TO .CSV FORMAT.

    Additional Manufacturer Narrative · 0

    H11. ADDITIONAL NARRATIVE: FIVE LINE ITEMS WITHIN THE ATTACHED .CSV FILE WERE UPDATED WITH ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 14 VALVE-IN-VALVE ADVERSE EVENTS THAT WOULD HAVE BEEN REPORTED TO THE FDA BETWEEN OCTOBER 1 AND DECEMBER 31, 2025 FOR PRODUCT CODE LWR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362980 HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES PRODUCT CODE LWR

    Patients

    Seq Age Sex Outcome Treatment
    1