BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 20295148 · Received September 24, 2024

    Report

    Report Number
    2015691-2024-07339
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    September 7, 2024
    Report Date
    November 5, 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 FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: B4, E1, G3, G6, H2, H6 AND H11. 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 EVENT DOES NOT ALLEGE A LABELING ISSUE OR DEVICE RELATED INFECTION; THEREFORE, NO DHR, LOT HISTORY REVIEW, OR MANUFACTURING MITIGATIONS REVIEW ARE REQUIRED. SINCE NO MANUFACTURING NON-CONFORMANCES WERE FOUND AND NO LABELING, TRAINING, OR IFU DEFICIENCIES WERE IDENTIFIED, NO PREVENTATIVE OR CORRECTIVE ACTIONS WERE REQUIRED.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION OF A 52MM EVOQUE VALVE PROCEDURE IN TRICUSPID POSITION. THE FINAL VALVE DEPLOYMENT POSITION WAS 0-5MM UNDER P/A AND S/L. ON POST-OPERATIVE DAY (POD) 2 THE PATIENT DEVELOPED AV-BLOCK, THIRD DEGREE AND ON POD 4 THE PATIENT HAD A PERMANENT PACEMAKER IMPLANTED. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017199 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850EV52 00690103212846

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention