BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 23694077 · Received December 2, 2025

    Report

    Report Number
    2015691-2025-09687
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    November 4, 2025
    Report Date
    December 23, 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
    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

    THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: B4, G3, G6, H2, H6 AND H11 THE COMPLAINT FOR VALVE INTERACTS WITH CONDUCTION SYSTEM WITH OTHER EMPIRICAL EVIDENCE VIA INFORMATION REPORTED BY EDWARDS CLINICAL SPECIALIST. THE DEVICE HISTORY RECORD WAS REVIEWED FINDING THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. BASED ON THIS REVIEW, NO NON-CONFORMANCES RELATED TO THE COMPLAINT EVENT WERE IDENTIFIED. 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. SINCE THERE ARE NO CONFIRMED PRODUCT OR LABELING, IFU, TRAINING MATERIAL NONCONFORMANCES AFFECTING DISTRIBUTED PRODUCT AND NO OTHER TRIGGERS HAVE BEEN MET, NO PREVENTATIVE OR CORRECTIVE ACTIONS ARE REQUIRED. THEREFORE, 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 A 56MM EVOQUE PROCEDURE. IT WAS REPORTED THAT ON POST-OPERATIVE DAY (POD)2, THE PATIENT EXPERIENCED A THIRD-DEGREE (COMPLETE) AV BLOCK. ON POD3, A PERMANENT PACEMAKER WAS IMPLANTED. HOWEVER, THE SUBSEQUENTLY PATIENT PASSED AWAY ON POD4. PATIENT HAD AORTIC VALVE STENOSIS AND MITRAL VALVE INSUFFICIENCY. THERE WERE NO ISSUES DURING THE PROCEDURE. FINAL VALVE DEPLOYMENT WAS IN GOOD POSITION AND STABLE WITHOUT ROCKING MOTION. THERE WAS MILD POSTEROSEPTAL PVL AND NO CENTRAL REGURGITATION WAS NOTICED. AFTER EVOQUE IMPLANTED, THE RIGHT VENTRICULAR FUNCTION WAS MILD IMPAIRED. ON POD#2 PATIENT EXPERIENCED A THIRD-DEGREE (COMPLETE) AV BLOCK. ON POD#3 A PERMANENT PACEMAKER (CS PM LEAD) WAS IMPLANTED. AFTER SEDATION FOR PACEMAKER IMPLANTATION, PATIENT BECAME SEVERE DESATURATED AND THEY WERE ABLE TO STABILIZE HIM AFTERWARDS. HOWEVER, AFTER PACEMAKER IMPLANTATION, POD#4 THE PATIENT PASSED AWAY ON ICU WHERE THEY NOTICED PERICARDIAL EFFUSION(PE) AND A PERICARDIAL PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898824 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850EV56 00690103219081

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Unknown Required Intervention