BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 21173502 · Received January 16, 2025

    Report

    Report Number
    2015691-2025-00366
    Event Type
    Injury
    Date Received
    January 16, 2025
    Date of Event
    December 19, 2024
    Report Date
    February 20, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPW
    UDI-DI
    00690103219081
    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 FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: B4, B5, G3, G6, H2, H6 AND H11. THE COMPLAINT FOR VALVE INTERACTS WITH CONDUCTION SYSTEM WAS CONFIRMED WITH OTHER EMPIRICAL EVIDENCE VIA INFORMATION PROVIDED BY EDWARDS CLINICAL SPECIALIST. IMAGERY WAS NOT PROVIDED FOR EVALUATION. AS SUCH, A DEFINITE ROOT CAUSE IS UNABLE TO BE DETERMINED. 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 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 MANUFACTURER'S INVESTIGATION IS ONGOING AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    AS REPORTED BY THE EDWARDS LIFESCIENCES AFFILIATE IN GERMANY, DURING THE PROCEDURE, AN INTERNAL TEMPORARY PACEMAKER WAS IMPLANTED AND ON POST-OPERATIVE DAY 1, A PERMANENT PACEMAKER (PPM) WAS IMPLANTED. PATIENT RECEIVED AN EVOQUE VALVE IN TRICUSPID POSITION WHERE, DURING THE PROCEDURE, THE PATIENT EXPERIENCED ATRIOVENTRICULAR (AV) BLOCK GRADE III DURING ATRIAL EXPANSION. THE VALVE WAS DEPLOYED AT ANNULAR LEVEL AND AN INTERNAL TEMPORARY VENOUS PACEMAKER WAS IMPLANTED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) WITH IT. ON POD 1, A LEADLESS PACEMAKER WAS IMPLANTED. ON POD 5, THE PATIENT WAS DISCHARGED.

    Description of Event or Problem · 0

    AS REPORTED BY THE EDWARDS LIFESCIENCES AFFILIATE IN GERMANY, A PATIENT RECEIVED AN EVOQUE VALVE IN TRICUSPID POSITION WHERE DURING THE PROCEDURE, THE PATIENT EXPERIENCED ATRIOVENTRICULAR (AV) BLOCK GRADE III DURING ATRIAL EXPANSION. THE VALVE WAS DEPLOYED AT ANNULAR LEVEL AND AN INTERNAL TEMPORARY VENOUS PACEMAKER WAS IMPLANTED. THE PATIENT'S OUTCOME WAS STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892275 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850EV56 00690103219081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention