BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 19667096 · Received July 3, 2024

    Report

    Report Number
    2015691-2024-05083
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    May 26, 2024
    Report Date
    July 25, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPW
    UDI-DI
    00690103212846
    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 AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE 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. 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. BASED ON THIS COMPLAINT INVESTIGATION, THE ROOT CAUSE OF THIS EVENT IS INDETERMINABLE.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION OF A 52MM EVOQUE PROCEDURE IN TRICUSPID POSITION. TWO (2) DAYS AFTER THE VALVE IMPLANTATION, PATIENT EXPERIENCED ATRIOVENTRICULAR BLOCK (AVB) LEADING TO THE IMPLANTATION OF A PERMANENT PACEMAKER (PPM) IN THE CORONARY SINUS. THE EDWARDS VALVE WAS IMPLANTED IN TRICUSPID POSITION. DURING THE IMPLANT PROCEDURE, ANESTHESIA NOTED THAT THE PATIENT WAS ALREADY SLOW WITH BRADYCARDIA HEART RHYTHM (30-40 BPM). INTRAPROCEDURAL EVERYTHING WAS FINE WITH OPTIMAL TRICUSPID REGURGITATION (TR) REDUCTION. THE IMPLANTATION OF THE VALVE WAS SUCCESSFUL. TWO (2) DAYS POST-PROCEDURE, THE PATIENT EXPERIENCED A NEW ATRIOVENTRICULAR BLOCK (AVB), AND A PERMANENT PACEMAKER (PPM) WAS IMPLANTED IN THE CORONARY SINUS. AS PER MEDICAL OPINION, THERE WAS NO ASSUMPTION THAT THE EVOQUE DEVICE LED TO THE IMPLANTATION OF THE PMM, AS THE PATIENT PRESENTED WITH BRADYCARDIA (BPM 30) PRE-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800297 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850EV52 00690103212846

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown Required Intervention