BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 21102198 · Received January 8, 2025

    Report

    Report Number
    2015691-2025-00139
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    December 12, 2024
    Report Date
    February 14, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPW
    UDI-DI
    00690103217520
    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

    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 DEVICE IS UNABLE TO MAINTAIN HEMOSTASIS - LEAKAGE DURING USE WAS CONFIRMED WITH EMPIRICAL EVIDENCE VIA AN INTERVIEW WITH THE CLINICAL SPECIALIST. AVAILABLE INFORMATION SUGGESTS THAT ABNORMAL USE (ACCESS VIA THE JUGULAR VEIN) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO MANUFACTURING NON-CONFORMITIES WERE IDENTIFIED. SINCE NO MANUFACTURING NON-CONFORMANCES WERE FOUND AND NO LABELING, TRAINING, OR IFU DEFICIENCIES WERE IDENTIFIED, NO PREVENTATIVE OR CORRECTIVE ACTIONS WERE REQUIRED.

    Description of Event or Problem · 0

    AS REPORTED, DURING DEVICE INSERTION THE SHEATH WAS ACCIDENTALLY RETRACTED OUT OF RIGHT INTERNAL JUGULAR (RIJ) AND CAREFULLY REINSERTED WITH HEMOSTASIS RE-ESTABLISHED. THIS REQUIRED 1 UNIT OF BLOOD TO BE ADMINISTERED, WITH 1 UNIT ON STANDBY. EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE DURING AN ATTEMPT TO CROSS THE TRICUSPID VALVE ANNULUS (TVA) FOR A RIGHT VENTRICULOGRAM WITH AGILIS SHEATH AND PIGTAIL CATHETER ONLY THE PATIENT DEVELOPED HEART BLOCK, PATIENT'S PACEMAKER WAS SENSING BUT NOT CAPTURING. BRIEF CPR STARTED AND PATIENT REGAINED SINUS RHYTHM. ELECTROPHYSIOLOGY (EP) CONSULT CALLED AND PATIENT'S DEVICE WAS INTERROGATED. BACK UP SETTINGS WERE ADJUSTED TO A HIGHER OUTPUT AFTER THRESHOLD ASSESSMENT OF RIGHT ATRIUM (RA) AND CORONARY SINUS (CS) LEADS. ATTEMPTED LEFT FEMORAL VEIN (LFV) ACCESS, DEVICE ADVANCED AND ATTEMPTED TO GET CENTRAL AND COAXIAL; EXPERIENCED RESISTANCE IN THE INFERIOR VENA CAVA (IVC) DISTAL TO IVC/RA JUNCTION WITH LIMITED SYSTEM ADVANCING ANTERIORLY. DEVICE WAS VERY DEEP IN THE RV WITH STRANGE TRAJECTORY DUE TO UNUSUAL ANATOMICAL RELATIONSHIP BETWEEN IVC AND TVA. DECISION MADE TO CONVERT TO RIGHT INTERNAL JUGULAR (RIJ) APPROACH. DEVICE INSERTION ATTEMPTED AND SHEATH WAS ACCIDENTALLY RETRACTED OUT OF RIJ, DEVICE WAS CAREFULLY REINSERTED AND HEMOSTASIS RE-ESTABLISHED. PATIENT EXPERIENCED BLOOD LOSS SIGNIFICANT ENOUGH TO NECESSITATE ADMINISTRATION OF 1 UNIT OF BLOOD, WITH 1 UNIT ON STANDBY. SYSTEM ADVANCED AND POSITIONED ACROSS TVA, WITH A VERY LATERAL TRAJECTORY. WIRE WAS IMAGED IN THE RV AND WAS NOTED TO BE IN A DIFFERENT POSITION FLUOROSCOPICALLY. SYSTEM AND WIRE RETRACTED. ECHO THOROUGHLY ASSESSED RV, WITH NO SIGNS OF RV INJURY, NO CLINICAL OR ECHO-GRAPHIC SIGNS OF TAMPONADE. TEAM DISCUSSED THAT WITH THE WIRE POSITION, GETTING CENTRAL AND COAXIAL WOULD BRING THE SYSTEM AGAIN TOO DEEP TO TREAT WITH THE LIMITATION OF BEING UNABLE TO PUSH WIRE FOR ADDED HEIGHT. DECISION MADE TO ABORT THE PROCEDURE AND THE DELIVERY SYSTEM REMOVED. PATIENT WAS STABLE AND TEAM DISCUSSED ADDITIONAL PROCEDURAL OPTIONS. DUE TO CURRENT STATUS OF THE PATIENT FROM TREATMENT ATTEMPTS, IT WAS DECIDED TO WAIT AND LET PATIENT RECOVER AND REATTEMPT NEXT MONTH, IF PATIENT AND FAMILY AGREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347764 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850TDSUS 65857599 00690103217520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention