BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 21800150 · Received April 8, 2025

    Report

    Report Number
    2015691-2025-02704
    Event Type
    Injury
    Date Received
    April 8, 2025
    Date of Event
    March 21, 2025
    Report Date
    May 22, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPW
    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 MANUFACTURER'S INVESTIGATION IS ONGOING AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL H6 TYPE OF INVESTIGATION CODES: 'ANALYSIS OF IMAGES' AND 'LABELLING REVIEW'. THE COMPLAINT FOR VALVE INTERACTS WITH CONDUCTION SYSTEM WAS CONFIRMED WITH EMPIRICAL EVIDENCE VIA INFORMATION REPORTED BY AN EDWARDS CLINICAL SPECIALIST. IMAGING EVALUATION WAS UNABLE TO DIRECTLY CONFIRM THE CONDUCTION DISTURBANCE. HOWEVER, FOLLOW-UP TTE SHOWED IMPLANTED PACEMAKER, WHICH EMPIRICALLY CONFIRMED THE CONDUCTION DISTURBANCE. DHR REVIEW WAS PERFORMED AND THERE WAS NO INDICATION THAT A MANUFACTURING NON-CONFORMANCE WOULD HAVE CONTRIBUTED TO THE COMPLAINT. AS SUCH, A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED. SINCE NO EDWARDS DEFECT WAS IDENTIFIED, CORRECTIVE OR PREVENTATIVE ACTIONS ARE NOT REQUIRED. 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE EDWARDS LIFESCIENCES AFFILIATE IN SWITZERLAND, EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE ON POD4 A TEMPORARY PACEMAKER (PM) WAS IMPLANTED AND ON POD5 A PERMANENT PM WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740837 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850EV44

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention