BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 19688870 · Received July 8, 2024

    Report

    Report Number
    2015691-2024-05166
    Event Type
    Injury
    Date Received
    July 8, 2024
    Date of Event
    April 26, 2024
    Report Date
    July 8, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPW
    UDI-DI
    00690103217568
    PMA / PMN Number
    P230013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT IS CAPTURED BY EDWARDS LIFESCIENCES UNDER COMPLAINT #: (B)(4). THIS IS A COMBINED INITIAL + FINAL REPORT WHICH CONTAINS THE INVESTIGATION FINDINGS BELOW. THE COMPLAINT FOR VALVE INTERACTS WITH CONDUCTION SYSTEM WAS CONFIRMED WITH OTHER EMPIRICAL EVIDENCE BASED ON THE COMPLAINT EVENT. 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. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED BECAUSE THE IMAGES WERE UNAVAILABLE FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE IN THE TRICUSPID POSITION WHERE A PATIENT WITH LONG-STANDING PERSISTENT ATRIAL FIBRILLATION RECEIVED A 52 MM EVOQUE VALVE IN AN INTENDED POSITION AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM. ON POSTOPERATIVE DAY (POD) 3, THE PATIENT DEVELOPED PAUSE FOR 4 MINUTES OR ABOVE AT MAXIMUM DUE TO COMPLETE ATRIOVENTRICULAR BLOCK AND A TEMPORARY PACEMAKER WAS PLACED. ON POD 7, THE TEMPORARY PACING LEAD WAS EXCHANGED TO ADJUST ITS POSITION. ON POD 9, A LEADLESS PACEMAKER WAS IMPLANTED. ON POD 13, THE PATIENT LEFT THE HOSPITAL WITH GOOD COURSE. PER THE PRINCIPAL INVESTIGATOR, DEPLOYMENT OF AN ARTIFICIAL VALVE CAN INTERVENE THE CONDUCTION SYSTEM AND CAN RESULT IN AN ATRIOVENTRICULAR BLOCK, WHICH CAN BE OBSERVED IN OTHER DEVICES AS WELL. THERE IS NO DEVICE MALFUNCTION OR DEFICIENCY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894694 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850EV52CLJ 00690103217568

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention