BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 4122547 · Received September 26, 2014

    Report

    Report Number
    2015691-2014-02258
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PER THE INSTRUCTIONS FOR USE, DEVICE MALPOSITION AND PARAVALVULAR LEAK ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TAVR PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO AORTIC MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMALLY OR SEVERELY CALCIFIED AORTIC LEAFLETS, PRESERVED EJECTION FRACTION, SIGNIFICANT MITRAL ANNULAR CALCIFICATION (MAC), LOSS OF PACING CAPTURE, AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICE AT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR TO THE PLACEMENT AND FIXATION OF THE DEVICE. OPERATORS ARE ALSO INSTRUCTED TO USE FLUOROSCOPY AS THE PRIMARY METHOD OF VISUALIZATION FOR POSITIONING AND DEPLOYMENT. IN PATIENTS WITH HIGH-RISK ANATOMICAL FEATURES FOR AORTIC MALPOSITION (I.E. MINIMAL LEAFLET CALCIFICATION, SEVERE SEPTAL HYPERTROPHY), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. IN THIS CASE, IT WAS REPORTED THAT THE PATIENT¿S SEVERELY CALCIFIED ANNULUS/LEAFLETS WAS LIKELY THE CAUSE OF THE MALPOSITION. THE PHYSICIAN WAS UNABLE TO CORRECT FOR THE VALVE MOVEMENT DURING DEPLOYMENT. IT IS ALSO POSSIBLE THAT THE REPORTED FAIR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM COULD ALSO HAVE BEEN A CONTRIBUTING FACTOR. THE SUBSEQUENT PVL WAS LIKELY A RESULT OF THE MALPOSITION OF THE VALVE, IN COMBINATION WITH THE SEVERE/BULKY NATIVE LEAFLET CALCIFICATION. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS (B)(4) AFFILIATE, DURING THE TRANSFEMORAL TAVR PROCEDURE, THE VALVE WAS POSITIONED IN A 50:50 POSITION; HOWEVER, DURING DEPLOYMENT THE VALVE SHIFTED AND LANDED 90:10 AORTIC/VENTRICULAR, WITH SEVERE PARAVALVULAR LEAK (PVL), RESULTING IN THE NEED FOR A SECOND VALVE. INITIALLY, THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE PLACING THE EXTRA STIFF WIRE IN THE LEFT VENTRICLE WITH THE CURVE ORIENTATED CORRECTLY. SIGNIFICANT EFFORTS WERE MADE TO REPOSITION THE WIRE. THE VALVULOPLASTY BALLOON (BAV) WAS INSERTED AND THE WIRE ORIENTATION CHANGED WITH THE BALLOON OVER THE WIRE. THE FIRST BAV SEEDED TO THE AORTA, AND THE SECOND BAV MOVED AORTIC AS WELL. THE 29MM SAPIEN XT VALVE WAS THEN CRIMPED AND POSITIONED 50:50 IN THE ANNULUS, HOWEVER, DURING DEPLOYMENT THE VALVE MOVED AND LANDED 90:10 A/V, WHICH RESULTED IN SEVERE PVL ASSOCIATED WITH SOME HEMODYNAMIC COMPROMISE. THE PRIMARY OPERATOR EXERTED FORWARD PRESSURE ON THE DELIVERY SYSTEM IN AN ATTEMPT TO HOLD THE VALVE IN THE CORRECT POSITION AND PREVENT EMBOLIZATION. A SECOND VALVE WAS PREPPED AND DEPLOYED 20:80 A/V, WHICH REDUCED THE REGURGITATION TO MILD. THE PATIENT WAS EXTUBATED IN THE OPERATING ROOM AND WAS TRANSFERRED TO THE CCU IN STABLE CONDITION. THE MALPOSITION WAS ATTRIBUTED TO THE PATIENT'S SEVERELY CALCIFIED AORTIC ANNULUS. THE NATIVE ANNULUS MEASURED BETWEEN 24-26MM BY TEE AND HAD AREA OF 640MM² BY CT. THE NATIVE ANNULUS AND LEAFLETS WERE SEVERELY CALCIFIED WITH BULKY CALCIFICATION. THE IMAGE INTENSIFIER ANGLE WAS REPORTED TO BE GOOD, THE COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND VALVE WAS REPORTED AS FAIR, VENTILATION WAS NOT HELD AND THERE WAS NO LOSS OF PACING CAPTURE DURING VALVE DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601335 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX29

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention