BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 19974460 · Received August 13, 2024

    Report

    Report Number
    2015691-2024-06081
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    July 14, 2024
    Report Date
    September 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 COMPLAINT FOR VALVE INTERACTS WITH CONDUCTION SYSTEM WAS CONFIRMED WITH OTHER EMPIRICAL EVIDENCE VIA INFORMATION REPORTED BY EDWARDS CLINICAL SPECIALIST. NO MANUFACTURING NON-CONFORMITIES WERE IDENTIFIED FROM THE DHR REVIEW. A DEFINITE ROOT CAUSE IS UNABLE TO BE DETERMINED. SINCE NO MANUFACTURING NON-CONFORMANCES WERE FOUND AND NO LABELING, TRAINING, OR IFU DEFICIENCIES WERE IDENTIFIED, NO PREVENTATIVE OR CORRECTIVE ACTIONS ARE REQUIRED.

    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.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE ON POST-OPERATIVE DAY (POD) 4, PATIENT DEVELOPED THIRD DEGREE AV-BLOCK. A PACEMAKER WAS IMPLANTED AND THE PATIENT WAS NOTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640335 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850EV52 00690103212846

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown Required Intervention