BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE VALVE

    MDR report key: 24840500 · Received April 10, 2026

    Report

    Report Number
    2015691-2026-14075
    Event Type
    Injury
    Date Received
    April 10, 2026
    Date of Event
    March 23, 2026
    Report Date
    May 18, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPW
    UDI-DI
    00690103217469
    PMA / PMN Number
    P230013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THE SAME EVENT. REFERENCE RELATED MANUFACTURER REPORT # 2015691 2026 13230. 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 A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. ONE MONTH POST INDEX PROCEDURE, A SECOND ATTEMPT TO IMPLANT AN EVOQUE WAS COMPLETED. AT FINAL POSITION OF THE VALVE POST DEPLOYMENT THE POSTERIOR DROPPED AND WAS NOTED TO BE LOW. THIS REQUIRED SNARING FROM IJ. A VALVE IN VALVE (VIV) WITH ANOTHER VALVE WAS THEN PERFORMED. FOLLOWING THE VIV, THE SNARE LASSO BECAME STUCK ON THE APICES. MILD AS COMMISSURAL PVL WAS PRESENT AFTER VIV, WITH NO CENTRAL REGURGITATION. THE PERCEIVED ROOT CAUSE OF THE EVENT WAS NOTED TO BE THE LACK OF LEAFLET ON POSTERIOR SIDE DUE TO PREVIOUS ENDOCARDITIS. THE PATIENT IS DOING WELL. DURING THE PROCEDURE, THE EP DID NOT WANT TO REMOVE THE PATIENT'S LEADS, SO LV ACCESS WAS GAINED FOR BACKUP WIRE TEMP PACING IF NEEDED DURING THE CASE WHICH DID NOT END UP BEING REQUIRED. DURING THE TIME OUT, CLINICAL DEVELOPMENT WAS CONSULTED. LEAFLET CAPTURE WAS CHALLENGING. THE LEAFLETS APPEARED CAPTURED EVEN THOUGH IMAGING WAS QUITE ROUGH. LIMITED LEAFLET TISSUE WAS PRESENT FROM THE 10 -12 O'CLOCK REGION IN THE SAX VIEW, A FINDING DISCUSSED IN ADVANCE AND REVIEWED WITH CLINICAL DEVELOPMENT. THIS PROMPTED PREPARATION FOR POTENTIAL SNARING AND VALVE IN VALVE INTERVENTION IF NEEDED AFTER RELEASE. THE ANCHORS WERE AT THE HINGE POINTS OF THE ANNULUS PRIOR TO FINAL VALVE RELEASE AND THE CASE PROCEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429790 EVOQUE VALVE PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850EV52US 00690103217469

    Patients

    Seq Age Sex Outcome Treatment
    1