BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3120880 · Received May 20, 2013

    Report

    Report Number
    2015691-2013-20132
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CINE AND ECHO IMAGES WERE SUBMITTED TO THE EDWARDS MEDICAL DIRECTOR FOR REVIEW. OBSERVATIONS: MODERATE-SEVERE AORTIC VALVE CALCIFICATION, MILD AORTIC ROOT CALCIFICATION, NO PORCELAIN AORTA, NO MITRAL ANNULAR CALCIFICATION (MAC); FAIR COAXIAL ALIGNMENT WITH LATERAL BIAS OF THE DELIVERY SYSTEM; POOR IMAGE INTENSIFIER ANGLE (IIA) AS MIDDLE CUSPS IS BELOW THE PLANE; POSITIONED 60:40 AORTIC AND MOVES VENTRICULAR DURING DEPLOYMENT TO A FINAL POSITION OF 60:40 VENTRICULAR. NO LOSS OF PACING CAPTURE AND VENTILATION HELD DURING VALVE DEPLOYMENT. NOTABLE VENTRICULAR MOVEMENT ABOUT 2/3 THROUGH INFLATION SUGGESTING THE POSSIBILITY OF A NARROWED CALCIFIED STJ; NO IMAGES AVAILABLE OF EMBOLIZED VALVE INTO THE VENTRICLE. IMPRESSIONS: POOR IIA CONTRIBUTED TO MALPOSITION AND THE REPORTED EMBOLIZATION OF THE VALVE. THERE IS NOTABLE VENTRICULAR MOVEMENT ABOUT 2/3 THROUGH INFLATION SUGGESTING THE POSSIBILITY OF A NARROWED CALCIFIED STJ. THIS COULD BE FURTHER SUPPORTED WITH ECHO OR CARDIAC CT WHICH IS NOT AVAILABLE FOR REVIEW. PER THE INSTRUCTIONS FOR USE (IFU), VALVE EMBOLIZATION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE SEVERAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VENTRICULAR MALPOSITION AND/OR EMBOLIZATION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, A NARROW, CALCIFIED SINOTUBULAR JUNCTION, MINIMAL VALVE CALCIFICATION, AND LOSS OF PACING CAPTURE. THE PROCEDURAL DIDACTIC INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING INCLUDES 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. IN THIS CASE, PER THE IMAGING REVIEW, A POOR IMAGE INTENSIFIER ANGLE CONTRIBUTED TO THE MALPOSITION AND SUBSEQUENT EMBOLIZATION OF THE VALVE. IN ADDITION, THERE WAS NOTABLE VENTRICULAR MOVEMENT ABOUT 2/3 THROUGH INFLATION, WHICH SUGGESTED THE POSSIBILITY OF A NARROWED CALCIFIED STJ. 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 AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, THE SAPIEN VALVE EMBOLIZED TO THE VENTRICLE AND PATIENT WAS CONVERTED TO SURGERY. DURING DEPLOYMENT OF THE VALVE THE DELIVERY SYSTEM VISIBLY MOVED VENTRICULAR AT THE LAST MOMENT OF DEPLOYMENT. THE WIRE WAS MAINTAINED TO KEEP THE VALVE ORIENTED THE CORRECT WAY AND THE PATIENT WAS PREPPED FOR CONVERSION TO SURGERY. THE VALVE WAS CRUSHED AND EXTRACTED THROUGH THE NATIVE VALVE. PATIENT REMAINED STABLE THROUGHOUT AND AS OF MONDAY /29/2013 THE PATIENT WAS STILL IN CVICU BUT EXTUBATED AND RECOVERING WELL ACCORDING TO THE SITE. THERE MAY HAVE BEEN SOME STORED ENERGY IN THE DELIVERY SYSTEM THAT WAS A CONSIDERATION OF CAUSE. THE NATIVE AORTIC ANNULAR DIAMETER WAS 25MM BY TEE. THE NATIVE AORTIC VALVE WAS MODERATELY CALCIFIED AND THE AORTIC ROOT WAS MILDLY CALCIFIED. THE DIAMETER OF THE SINOTUBULAR JUNCTION (STJ) WAS 23.2MM. THE PATIENT¿S EJECTION FRACTION WAS 50%. DURING VALVE DEPLOYMENT, VENTILATION WAS HELD AND THERE WAS NO LOSS OF PACING CAPTURE. THE IMAGE INTENSIFIER ANGLE (IIA) WAS DESCRIBED AS GOOD. THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WAS DESCRIBED AS FAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222146 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention