BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INTUITY ELITE VALVE SYSTEM

    MDR report key: 21908832 · Received April 25, 2025

    Report

    Report Number
    2015691-2025-03255
    Event Type
    Injury
    Date Received
    April 25, 2025
    Report Date
    June 2, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P150036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. 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

    INITIALLY, IT WAS REPORTED THAT WHEN IMPLANTING AN INTUITY 8300AB VALVE, THE SURGEON EXPERIENCED THE NEED TO IMPLANT A PACEMAKER. HOWEVER, THROUGH INVESTIGATION IT WAS LEARNED THAT THE PATIENT DEVELOPED A CONDUCTION DISTURBANCE THAT RESOLVED AFTER FOUR (4) DAYS. NO PERMANENT PACEMAKER WAS IMPLANTED. HEART BLOCK, AND OTHER CONDUCTION DISTURBANCES ARE COMMON IN PATIENTS WITH UNDERLYING CARDIOVASCULAR DISEASE AND/OR CONDUCTION ABNORMALITIES. THE REASON FOR POST-OPERATIVE ATRIOVENTRICULAR (AV) BLOCK AFTER AORTIC VALVE REPLACEMENT (AVR) WITH INTUITY VALVE IS RELATED TO INJURY TO THE CARDIAC CONDUCTION SYSTEM DUE TO INAPPROPRIATE SUTURE PLACEMENT CAUSING INJURY TO CONDUCTION SYSTEM, EDEMA, AND INFLAMMATION OF ADJACENT TISSUE SURROUNDING CONDUCTION TISSUE. EXPANSION OF THE SUBANNULAR STENT WITHIN THE LVOT COULD POSSIBLY EXERT COMPRESSION ON THE CONDUCTION SYSTEM. THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE AORTIC VALVULAR COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE EXPLAINS THE POSSIBLE DEVELOPMENT OF CONDUCTION ABNORMALITIES FOLLOWING PROSTHETIC AORTIC VALVE PROCEDURES. IN THIS CASE, A PERMANENT PACEMAKER WAS NOT REQUIRED WITHIN 30 DAYS AFTER IMPLANT, AND THERE WAS NO HARM TO THE PATIENT. THIS IS NOT A DEVICE-RELATED SERIOUS INJURY. BASED ON THE ADDITIONAL INFORMATION OBTAINED, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE AND THIS CORRECTION IS BEING SUBMITTED.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION THAT WHEN IMPLANTING AN EDWARDS INTUITY VALVE 8300AB OF UNKNOWN SIZE, THE SURGEON EXPERIENCED THE NEED TO IMPLANT A PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481304 EDWARDS INTUITY ELITE VALVE SYSTEM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 8300AB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R| L