BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 19813298 · Received July 23, 2024

    Report

    Report Number
    2015691-2024-05599
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    June 27, 2024
    Report Date
    August 22, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPW
    UDI-DI
    00690103217544
    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 COMPLAINT FOR VALVE INTERACTS WITH CONDUCTION SYSTEM WAS CONFIRMED WITH OTHER EMPIRICAL EVIDENCE VIA INFORMATION PROVIDED BY EDWARDS CLINICAL SPECIALIST. IMAGING EVALUATION CANNOT CONFIRM ANY DEVICE RELATED ISSUES OR MALFUNCTION CONTRIBUTING TO THE EVENT. THE ROOT CAUSE FOR CONDUCTION DISTURBANCE IS INDETERMINABLE WITH POSSIBLE CONTRIBUTING FACTORS BEING PATIENT HISTORY OF RBBB. ALSO, CANNOT CONFIRM ANY DEVICE RELATED ISSUES OR MALFUNCTION. 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.

    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.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE IN TRICUSPID POSITION WHERE ON POSTOPERATIVE DAY (POD) 2, A LONG PAUSE WAS OBSERVED WHEN THE PRE-EXISTING PAROXYSMAL ATRIAL FIBRILLATION OF THE PATIENT RETURNED TO SINUS RHYTHM, WHICH WAS DIAGNOSED AS SICK SINUS SYNDROME. ON POD 3, A TEMPORARY PACING CATHETER WAS INSERTED, AND IT RESULTED IN PROLONGED HOSPITAL STAY. THE PATIENT DEVELOPED COMPLETE ATRIOVENTRICULAR BLOCK ON POD 6. A SINGLE CHAMBER PACEMAKER WAS IMPLANTED ON POD 8. THERE WAS NO ALLEGATION OF ANY DEVICE DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344052 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850EV44CLJ 00690103217544

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Hospitalization| R