BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 22610316 · Received July 25, 2025

    Report

    Report Number
    2015691-2025-06058
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    July 14, 2025
    Report Date
    September 2, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPW
    UDI-DI
    00690103212839
    PMA / PMN Number
    P230013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: B4, G3, G6, H2, AND H11: ADDITIONAL INFORMATION PROVIDED STATES THAT A PERMANENT PACEMAKER WAS IMPLANTED DAY 2 AFTER IMPLANTATION. THE PATIENT WAS STABLE AND DISCHARGED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS ONGOING AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT FOR VALVE INTERACTS WITH CONDUCTION SYSTEM WAS CONFIRMED WITH OTHER EMPIRICAL EVIDENCE VIA INFORMATION REPORTED BY EDWARDS CLINICAL SPECIALIST. AS REPORTED, THE PATIENT DEVELOPED HEART BLOCK THAT REQUIRED A PERMANENT PACEMAKER IMPLANTATION. PER THE INSTRUCTIONS FOR USE (IFU), CONDUCTION SYSTEM DISTURBANCE AND/OR HEART BLOCK WHICH MAY REQUIRE TREATMENT (INCLUDING PERMANENT PACEMAKER) ARE POTENTIAL ADVERSE EVENTS. HEART BLOCK AND OTHER CONDUCTION DISTURBANCES ARE COMMON IN PATIENTS WITH UNDERLYING CARDIOVASCULAR DISEASE AND CAN BE EXACERBATED OR AGGRAVATED WITH STANDARD INTRA-OPERATIVE MEDICATIONS OR ANESTHESIA. SUCH EVENTS ARE RELATED TO THE PATIENT'S UNDERLYING CONDITION. OTHER MECHANISMS FOR CONDUCTION ABNORMALITIES COULD BE RELATED TO CORONARY OBSTRUCTION DUE TO AIR EMBOLISM, CORONARY SPASM AND/OR LOCAL EDEMA AFFECTING THE AV NODE. CONDUCTION DISTURBANCES HAVE ALSO BEEN DOCUMENTED DURING TRANSCATHETER CARDIAC PROCEDURES AS A RESULT OF DIRECT INTERACTION WITH CARDIAC ANATOMY, ESPECIALLY IN PATIENTS WITH UNDERLYING CONDUCTION ABNORMALITIES. OTHER POTENTIAL CAUSES INCLUDE TRAUMA BY A GUIDEWIRE OR DELIVERY SYSTEM. ADDITIONALLY, CARDIAC CONDUCTION SYSTEM COMPLICATIONS ARE KNOWN RISKS WITH TRICUSPID VALVE INTERVENTIONS DUE TO THE PROXIMITY OF THE ATRIOVENTRICULAR NODE (AV NODE) TO THE SEPTAL LEAFLET OF THE TRICUSPID VALVE. THESE CONDUCTION DISTURBANCES CAN LEAD TO POST-OPERATIVE HEART BLOCK REQUIRING PACEMAKER IMPLANTATION. NEVERTHELESS, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SINCE THERE ARE NO CONFIRMED PRODUCT OR LABELING/IFU/TRAINING MATERIAL NON-CONFORMANCES AFFECTING DISTRIBUTED PRODUCT AND NO OTHER TRIGGERS HAVE BEEN MET, NO PREVENTATIVE OR CORRECTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    AS REPORTED BY THE EDWARDS LIFESCIENCES AFFILIATE IN GERMANY, EDWARDS RECEIVED NOTIFICATION OF A 48MM EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE DURING PROCEDURE, THE PATIENT EXPERIENCED COMPLETE ATRIOVENTRICULAR BLOCK (AVB) AFTER DEPLOYMENT OF THE VALVE, WHICH WAS POSITIONED AT ANNULAR LEVEL. THE HEART BLOCK PROGRESSED, AND THE DECISION WAS MADE TO IMPLANT A PERMANENT PACEMAKER ON THE SAME DATE OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2287164 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850EV48 11266017 00690103212839

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention