BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 19353243 · Received May 20, 2024

    Report

    Report Number
    2015691-2024-03756
    Event Type
    Injury
    Date Received
    May 20, 2024
    Date of Event
    April 27, 2024
    Report Date
    July 3, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPW
    UDI-DI
    00690103217445
    PMA / PMN Number
    P230013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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, G3, G6, H2, H6 AND H11. THE COMPLAINT FOR VALVE INTERACTS WITH CONDUCTION SYSTEM WAS CONFIRMED WITH OTHER EMPIRICAL EVIDENCE BASED ON THE COMPLAINT EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF AVAILABLE IMAGES FOR FURTHER INVESTIGATION. 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 COMPLETE HEART BLOCK ON POST OP DATE (POD) 1, WHICH REQUIRED PLACEMENT OF A PERMANENT PACEMAKER ON (POD) 3. EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE POST PROCEDURE, PATIENT DEVELOPED RIGHT BUNDLE BRANCH BLOCK (RBBB). ON (POD) 1, IT WAS REPORTED THE PATIENT DEVELOPED COMPLETE HEART BLOCK AND A TEMPORARY PACEMAKER WAS PLACED. ON (POD) 3, A PERMANENT PACEMAKER WAS PLACED VIA TEE GUIDANCE WITH A SMALL SEPTAL LEAD THROUGH EVOQUE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993684 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850EV44US 00690103217445

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention