BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 19732201 · Received July 12, 2024

    Report

    Report Number
    2015691-2024-05329
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    June 15, 2024
    Report Date
    August 19, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPW
    UDI-DI
    00690103217551
    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 EVENT IS CAPTURED BY EDWARDS LIFESCIENCES UNDER COMPLAINT #: (B)(4). THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT FOR VALVE INTERACTS WITH CONDUCTION SYSTEM WAS CONFIRMED WITH OTHER EMPIRICAL EVIDENCE VIA INFORMATION PROVIDED BY EDWARDS CLINICAL SPECIALIST. THE REPORTED CONDUCTION DISTURBANCE DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO AN EDWARDS MANUFACTURING DEFICIENCY. THE ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE IN THE TRICUSPID POSITION WHERE THE PATIENT HAD LONG-STANDING PERSISTENT ATRIAL FIBRILLATION AND RIGHT BUNDLE BRANCH BLOCK AT BASELINE AND NOW RECEIVED A 48MM EVOQUE VALVE IN AN INTENDED POSITION AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ON POSTOPERATIVE DAY (POD) 4, THE PATIENT DEVELOPED COMPLETE ATRIOVENTRICULAR BLOCK AND A TEMPORARY PACEMAKER WAS PLACED. THERE IS NO DEVICE MALFUNCTION OR DEFICIENCY REPORTED SO FAR. ADDITIONAL INFORMATION RECEIVED FROM THE CLINICAL SPECIALIST STATED THAT ON POD 9, THE TEMPORARY PACING CATHETER WAS REPLACED TO ADJUST THE POSITION OF THE PACING LEAD. POD 15, A LEADLESS PACEMAKER WAS IMPLANTED. POD 18, THE PATIENT LEFT THE HOSPITAL WITH GOOD COURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142756 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850EV48PCLJ 00690103217551

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Required Intervention