BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3971744 · Received July 31, 2014

    Report

    Report Number
    2015691-2014-01750
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OF THE FIRST VALVE EMBOLIZATION IS REPORTED UNDER MDR REPORT NUMBER 2015691-2014-01749. 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 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. IN THIS CASE, THE INITIAL CAUSE OF THE EMBOLIZATION WAS DUE TO VALVE UNDERSIZING. THE LOSS OF PACING CAPTURE CAUSED MALPOSITION OF THE SECOND VALVE, RESULTING IN CAI. A THIRD VALVE WAS PLACED WITHIN THE ANNULUS CORRECTING THE CAI. 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    UPON DEFLATION OF THE DELIVERY SYSTEM BALLOON CATHETER, THE 23MM SAPIEN XT EMBOLIZED INTO THE AORTA. A SECOND VALVE WAS DEPLOYED BUT EMBOLIZED AS WELL. A 23MM SAPIEN XT VALVE WAS PREPPED AND ADVANCED WITH NO ISSUES. THE VALVE WAS POSITIONED 50/50 ACROSS THE ANNULUS AND THE BALLOON WAS INFLATED. UPON DEFLATION OF THE BALLOON CATHETER, THE 23MM SAPIEN XT EMBOLIZED INTO THE AORTA. THE VALVE WAS PULLED BACK TO THE DESCENDING AORTA WITH A 30MM CODA BALLOON. ADDITIONAL POST DILATATION OF THE VALVE WAS DONE IN DESCENDING AORTA AND A SECOND VALVE WAS PREPPED. THE SECOND VALVE WAS ADVANCED ACROSS THE ANNULUS AND POSITIONED 50/50. RAPID PACING WAS INITIATED AND THE BALLOON WAS INFLATED. DURING INFLATION, PACING CAPTURE WAS LOST AND A PVC CAUSED THE VALVE TO MOVE AORTIC. THE SECOND VALVE MOVED TO THE LEVEL OF THE SINOTUBULAR JUNCTION (STJ), RESULTING IN CENTRAL AORTIC INSUFFICIENCY (CAI). A THIRD VALVE WAS PREPPED AND DEPLOYED 50/50 ACROSS THE ANNULUS WITH NO ISSUE. THE PATIENT REMAINED STABLE THROUGHOUT THE ENTIRE PROCEDURE. THE PERCEIVED CAUSE OF EMBOLIZATION OF THE FIRST VALVE WAS UNDERSIZING. THE PATIENT¿S NATIVE ANNULUS DIAMETER WAS 20-21MM BY TEE, AND 19MM BY TTE. THERE WAS MODERATE NATIVE VALVE/LEAFLET CALCIFICATION, AND THE PATIENT¿S EJECTION FRACTION (EF) WAS 70%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447632 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention