BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 20101840 · Received August 29, 2024

    Report

    Report Number
    2015691-2024-06744
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    January 30, 2024
    Report Date
    August 29, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPW
    PMA / PMN Number
    P230013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT IS CAPTURED BY EDWARDS LIFESCIENCES UNDER COMPLAINT #: (B)(4).. THE COMPLAINT FOR VALVE DEPLOYED TOO VENTRICULAR POSITION WAS CONFIRMED WITH OBJECTIVE EVIDENCE WITH THE PROVIDED IMAGES. NO MANUFACTURING OR FUNCTIONAL NON-CONFORMITIES WERE FOUND OR IDENTIFIED FROM THE IMAGING EVALUATION. AVAILABLE INFORMATION SUGGESTS THAT THE PATIENT CONDITIONS ALSO CONTRIBUTED TO THE EVENT. SINCE NO MANUFACTURING NON-CONFORMANCES WERE FOUND AND NO LABELING, TRAINING, OR IFU DEFICIENCIES WERE IDENTIFIED, NO PREVENTATIVE OR CORRECTIVE ACTIONS ARE REQUIRED. FOR THE ADDITIONAL INFORMATION PROVIDED, THE PATIENT RETURNED TO THE SITE FOR ADDITIONAL PERCUTANEOUS INTERVENTION. NO ADDITIONAL IMAGING WAS RECEIVED TO CONFIRM EVOQUE VALVE CHANGES THAT LED TO THE TREATING THE PATIENT WITH A SAPIEN VALVE.

    Description of Event or Problem · 0

    AS REPORTED, DURING THE PROCEDURE AFTER VALVE DEPLOYMENT, THE PATIENT EXPERIENCED TRICUSPID REGURGITATION (TR) GRADE III. ON POST-OPERATIVE DAY (POD) 77, THE PATIENT RECEIVED IMPLANTATION OF A SAPIEN VALVE. EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE IT WAS REPORTED DURING THE PROCEDURE, THE ANTERIOR SIDE OF THE VALVE BEFORE RELEASE, WAS LOWER THAN POSTERIOR. WHEN THIS WAS IDENTIFIED, THE SYSTEM WAS RETRACTED (TO BRING UP ANTERIOR SIDE VIA TILTING). AT THE END OF THE PROCEDURE WHEN THE VALVE WAS DEPLOYED, THE ANTERIOR PORTION CAME DOWN AND THE POSTERIOR PORTION OF THE VALVE FRAME LOOKED COMPRESSED. SINCE THE VALVE CHANGED POSITION DURING RELEASE, IT CREATED TR GRADE III (COMBINATION OF PARAVALVULAR LEAK AND VALVULAR LEAK). REPORTEDLY A COMBINATION OF FACTORS WITH A RHEUMATIC MORPHOLOGY (THICKENED AND CURLED LEAFLETS), AS WELL AS CHORDAE FUSED TOGETHER AND STIFFER (FIBROTIC) PAPILLARY MUSCLES. THIS MORPHOLOGY LIKELY BROUGHT THE VALVE DOWN AFTER DEPLOYMENT. VALVE WAS STABLE AND IN POSITION DIRECTLY AFTER RELEASE (NO ROCKING MOTION). PATIENT WAS NOTED AS TO BE STABLE AT ALL TIMES, WAS DOING WELL, AND WAS DISCHARGED. AS PER ADDITIONAL INFORMATION RECEIVED, ON POD 72, THE SITE INDICATED THE PATIENT WAS NOT DOING WELL AND THEY PLANNED ON INITIATING TREATMENT WITH A BALLOON DILATION OR A SAPIEN VALVE. A SAPIEN VALVE WAS IMPLANTED ON POD 77.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354871 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850EV48

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R