BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 19689366 · Received July 8, 2024

    Report

    Report Number
    2015691-2024-05168
    Event Type
    Injury
    Date Received
    July 8, 2024
    Date of Event
    June 12, 2024
    Report Date
    August 7, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPW
    UDI-DI
    00690103217469
    PMA / PMN Number
    P230013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT FOR VALVE DEPLOYED TOO VENTRICULAR POSITION AND CENTRAL REGURGITATION WAS CONFIRMED WITH EMPIRICAL EVIDENCE PER THE DESCRIPTION FROM THE CLINICAL SPECIALIST. NO MANUFACTURING OR FUNCTIONAL NON-CONFORMITIES WERE FOUND OR IDENTIFIED FROM THE IMAGING EVALUATION. AVAILABLE INFORMATION SUGGESTS THAT THE PROCEDURAL, PATIENT RELATED, AND IMAGING ISSUES MAY HAVE CONTRIBUTED TO THE EVENT. HOWEVER, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED SINCE NO IMAGES WERE PROVIDED FOR REVIEW.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE IN TRICUSPID POSITION WHERE IT WAS UNABLE TO GAIN HEIGHT AFTER ARM FLIP. THE VALVE WAS DEPLOYED 2 CM LOW AND TILTED. THE PHYSICIAN WAS ABLE TO PUSH THE EVOQUE VALVE BACK INTO PLACE WITH THE DELIVERY SYSTEM BUT POSSIBLY DAMAGED THE LEAFLET. THE PROCEDURE WAS COMPLETED WITH A REDUCTION OF TR (TRICUSPID REGURGITATION) FROM TORRENTIAL TO SEVERE. THE PATIENT DID HAVE SIGNS OF IMPROVEMENT. THE CLINICAL SPECIALIST FURTHER STATED THAT ALL THE CORRECT STEPS WERE TAKEN AND AT TIMEOUT THE TEAM BELIEVED THEY WOULD BE ABLE TO DEPLOY SAFELY WITH ADEQUATE IMAGING. ONCE IT WAS REALIZED THAT THE TEAM WAS MORE VENTRICULAR THAN THOUGHT, EVERY MANEUVER WAS ATTEMPTED TO GET ATRIAL. UNFORTUNATELY, THE IVC/DELIVERY SYSTEM WERE NOT TRANSLATING THESE ATTEMPTS. THE PHYSICIANS DID BELIEVE IT WAS GOING TO BE OKAY AND PEEKED ANCHORS, WENT TO 45 DEGREES WITH ANCHORS THEN 90 DEGREES WITH ANCHORS WHERE THEY BECAME CAUGHT. ALL MANEUVERS WERE CORRECTLY EXECUTED BEFORE DEPLOYMENT. ANCHORS WERE AT 45 AND THE TEAM WAS COMMITTED TO DEPLOYING THE VALVE AT THAT POINT. THE TEAM MUST HAVE CAUGHT ON A CHORD OR PAPILLARY NOT WELL SEEN BY ECHO. TEE AND ICE WERE BOTH USED AND WERE OPTIMAL ENOUGH AT TIMEOUT BUT AS THE PROCEDURE WENT ON IT BECAME WORSE. IT WAS VERY DIFFICULT TO SEE SUBVALVULAR APPARATUS. IMAGING WAS VERY DIFFICULT BOTH WITH TEE AND ICE. THERE WAS A HIGH PAPILLARY MUSCLE, BUT IT LOOKED LIKE IT WOULD BE ABLE TO CLEAR IT WITH THE ANCHORS. AGAIN, POOR IMAGING AND NOT HAVING ANY ADDITIONAL MANEUVERS WERE LEFT TO USE TO GAIN HEIGHT. THE VALVE EXPANDED AS EXPECTED. THE PATIENT IS STABLE AND DISCHARGED AND IS BEING FOLLOWED UP FOR TR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894711 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850EV52US 00690103217469

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention