BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 21599994 · Received March 13, 2025

    Report

    Report Number
    2015691-2025-01896
    Event Type
    Injury
    Date Received
    March 13, 2025
    Date of Event
    February 17, 2025
    Report Date
    April 17, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPW
    UDI-DI
    00690103217469
    PMA / PMN Number
    P230013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: B4, G3, G6, H2, H6 AND H11 TYPE OF INVESTIGATION INCLUDES ANOTHER CODE: LABELLING REVIEW 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 ENCOUNTERED HEART BLOCK AFTER THE DELIVERY SYSTEM HAD CROSSED THE ANNULUS, WHICH RESULTED IN 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. FURTHERMORE, THE DHR REVIEW WAS PERFORMED AND THERE WAS NO INDICATION OF A MANUFACTURING NON-CONFORMANCE THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT. SINCE NO EDWARDS DEFECT WAS IDENTIFIED, CORRECTIVE OR PREVENTATIVE ACTIONS ARE NOT 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

    EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE, DURING THE PROCEDURE, THE PATIENT WENT INTO HEART BLOCK WHEN THE DELIVERY SYSTEM (DS) CROSSED THE ANNULUS. THE TEAM PACED OFF THE SAFARI WIRE TO COMPLETE THE PROCEDURE AND THEN A PERMANENT PACEMAKER (PPM) WAS IMPLANTED IMMEDIATELY POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482526 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850EV52US 00690103217469

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention