BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 20689164 · Received November 14, 2024

    Report

    Report Number
    2015691-2024-08640
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    October 24, 2024
    Report Date
    February 12, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPW
    UDI-DI
    00690103212846
    PMA / PMN Number
    P230013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT FOR VALVE INTERACTS WITH CONDUCTION SYSTEM WAS CONFIRMED WITH OTHER EMPIRICAL EVIDENCE VIA INFORMATION PROVIDED BY EDWARDS CLINICAL SPECIALIST. THE REPORTED CONDUCTION DISTURBANCE DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO AN EDWARDS MANUFACTURING DEFICIENCY. THE EVENT DOES NOT ALLEGE A LABELING ISSUE OR DEVICE RELATED INFECTION; THEREFORE, NO DHR, LOT HISTORY REVIEW, OR MANUFACTURING MITIGATIONS REVIEW ARE REQUIRED. SINCE NO MANUFACTURING NON-CONFORMANCES WERE FOUND AND NO LABELING, TRAINING, OR IFU DEFICIENCIES WERE IDENTIFIED, NO PREVENTATIVE OR CORRECTIVE ACTIONS WERE REQUIRED.

    Additional Manufacturer Narrative · 0

    THE EVENT IS CAPTURED BY EDWARDS LIFESCIENCES UNDER COMPLAINT#: (B)(4). THE MANUFACTURER'S INVESTIGATION IS ONGOING AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: B4, B5, B7, G3, G6, H2, H6 AND H11.

    Description of Event or Problem · 0

    AS REPORTED BY THE EDWARDS LIFESCIENCES AFFILIATE IN AUSTRIA, A PATIENT RECEIVED AN EVOQUE VALVE IN TRICUSPID POSITION WHERE THE VALVE WAS SUCCESSFULLY IMPLANTED WITH VALVE DEPLOYMENT POSITION IN ALL PLANES 0-5MM ON ANNULAR LEVEL. DIRECTLY AFTER VALVE RELEASE, THE PATIENT HAD BRADYARRHYTHMIA ABSOLUTA WITH ALREADY EXISTING ATRIAL FIBRILLATION. TEMPORARY RIGHT VENTRICULAR (RV) PACEMAKER LEAD IMPLANTATION THROUGH EVOQUE VALVE. ON POST-OPERATIVE (POD) 1, A PERMANENT PACEMAKER WAS SUCCESSFULLY IMPLANTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE EDWARDS LIFESCIENCES AFFILIATE IN AUSTRIA, A PATIENT RECEIVED AN EVOQUE VALVE IN TRICUSPID POSITION WHERE THE VALVE WAS SUCCESSFULLY IMPLANTED WITH VALVE DEPLOYMENT POSITION IN ALL PLANES 0-5MM ON ANNULAR LEVEL. DIRECTLY AFTER VALVE RELEASE, THE PATIENT HAD BRADYARRHYTHMIA ABSOLUTA AND A THIRD DEGREE AV BLOCK WITH ALREADY EXISTING ATRIAL FIBRILLATION. TEMPORARY RIGHT VENTRICULAR (RV) PACEMAKER LEAD IMPLANTATION THROUGH EVOQUE VALVE. ON POST-OPERATIVE (POD) 1, A PERMANENT PACEMAKER WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2285418 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850EV52 00690103212846

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention