BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE VALVE

    MDR report key: 24654616 · Received March 20, 2026

    Report

    Report Number
    2015691-2026-13400
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    March 2, 2026
    Report Date
    April 29, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPW
    UDI-DI
    00690103219081
    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

    E1 TELEPHONE NUMBER: (B)(6). 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

    AS REPORTED BY THE EDWARDS LIFESCIENCES AFFILIATE IN GERMANY, EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE DAY OF THE PROCEDURE, THERE WAS NOT AN APPROPRIATE VOLUME OPTIMIZATION. THE PATIENT EXPERIENCED A GRADE III AV BLOCK, THEREFORE A TEMPORARY PACEMAKER WAS IMPLANTED AT THE END OF THE PROCEDURE. ON POST OPERATIVE DAY (POD) 2, A PERMANENT PACEMAKER WAS IMPLANTED. ON POD 3, THE PATIENT WAS DISCHARGED IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601983 EVOQUE VALVE PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850EV56 00690103219081

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention