BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 19431882 · Received May 30, 2024

    Report

    Report Number
    2015691-2024-04040
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    May 2, 2024
    Report Date
    June 27, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPW
    PMA / PMN Number
    P230013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. AS NO IMAGING WAS RETURNED, NO INVESTIGATION COULD BE PERFORMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE REPORTED CONDUCTION DISTURBANCE DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO AN EDWARDS MANUFACTURING DEFICIENCY.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT EXPERIENCED CONDUCTION DISTURBANCE DURING THE PROCEDURE REQUIRING TEMPORARY PACING, WITH PLANS FOR A PERMANENT PACE MAKER (PPM) POST PROCEDURE. EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE IT WAS REPORTED THE PATIENT EXPERIENCED CONDUCTION DISTURBANCE DURING THE PROCEDURE, WHICH REQUIRED TEMPORARY PACING OVER THE SAFARI WIRE. ADDITIONALLY REPORTED, ARE PLANS FOR PERMANENT PACE MAKER (PPM) IMPLANTATION POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311808 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850EV52US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention