BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 4150196 · Received October 7, 2014

    Report

    Report Number
    2015691-2014-02348
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, DEVICE EMBOLIZATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO AORTIC EMBOLIZATION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMALLY CALCIFIED AORTIC LEAFLETS, PRESERVED EJECTION FRACTION, AND LOSS OF PACING CAPTURE. 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 XT 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 EMBOLIZATION (I.E. MINIMAL LEAFLET CALCIFICATION, SEVERE SEPTAL HYPERTROPHY), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT IMAGING OF THE PROCEDURE WAS NOT AVAILABLE FOR EDWARDS LIFESCIENCES TO REVIEW. WITHOUT IMAGING, PATIENT FACTORS (NATIVE VALVE CALCIFICATION), AND PROCEDURAL FACTORS (IMAGING INTENSIFIER ANGLE, VALVE DEPLOYMENT POSITION, CONFIRMATION OF LEAFLET MOTION RESTRICTION OR OVERHANG) COULD NOT BE CONFIRMED/ASSESSED. THE CAUSE OF THE REPORTED VALVE EMBOLIZATION INTO THE AORTA CANNOT BE CONFIRMED. HOWEVER, IT APPEARS TO BE RELATED TO THE PATIENT¿S NARROW LVOT CAUSING THE VALVE TO MOVE UPWARDS DURING DEPLOYMENT. THERE WAS NO ALLEGATION OR INDICATION THAT THE EVENT WAS RELATED TO A MANUFACTURING DEFECT OF THE DEVICE. 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 OUR (B)(4) AFFILIATE, DURING A TRANSFEMORAL TAVR PROCEDURE THE BALLOON MOVED DURING DEPLOYMENT AND THE 23MM SAPIEN XT VALVE WAS IMPLANTED IN THE SINUS OF VALSALVA (SOV). PRE-PROCEDURE, THE RISK FOR THE BALLOON BEING PUSHED AORTIC DURING DEPLOYMENT WAS CONSIDERED HIGH DUE TO THE PATIENT¿S NARROW LVOT (15.2 X 19.4MM BY 3-D ECHO). DURING BALLOON AORTIC VALVULOPLASTY (BAV), THE BALLOON MOVED SLIGHTLY AORTIC. THE OPERATOR CONFIRMED THAT THE BALLOON COULD BE EASILY MOVED AND DECIDED TO IMPLANT A 23MM SAPIEN XT WITH 1ML LESS THAN NOMINAL VOLUME, UNDER SLOW INFLATION. THE XT VALVE WAS POSITIONED 50:50 AORTIC/VENTRICULAR (A/V), BUT DURING FASTER INFLATION THAN PLANNED, THE BALLOON POPPED UP. SINCE THE BALLOON WAS INFLATED TOO FAST THERE WAS NO TIME TO ADJUST ITS POSITION AND THE XT VALVE WAS DEPLOYED IN THE SOV. WHEN THE PACING WAS TURNED OFF, THE XT VALVE HAD SLOWLY MIGRATED TO THE AORTIC SIDE. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO PULL THE XT VALVE UP TO THE DESCENDING AORTA, BUT THE AORTIC ARCH WAS NARROW AND THE CALCIFICATION IN ITS LESSER CURVATURE BLOCKED THE XT VALVE. IT WAS DECIDED TO ANCHOR THE VALVE WHERE IT WAS; SLIGHTLY PASSED THE LEFT SUBCLAVIAN ARTERY. THERE WAS CONCERN OF ATTEMPTING TO IMPLANT ANOTHER VALVE BECAUSE OF THE RESISTANCE FELT WHEN THE DELIVERY SYSTEM PASSED THE ILIAC ARTERY. THE BAV WORKED EFFECTIVELY, WHICH RESULTED IN SIGNIFICANT IMPROVEMENT OF THE GRADIENT, AND CONSIDERING THE PATIENT¿S ADVANCED AGE, IT WAS DECIDED TO MONITOR THE PATIENT AND TO DISCUSS THE TREATMENT POLICY AGAIN IF SYMPTOMS DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627849 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23J

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention