BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2802152 · Received October 23, 2012

    Report

    Report Number
    2015691-2012-18527
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EDWARDS LIFESCIENCES MADE MULTIPLE ATTEMPTS TO REVIEW THE IMAGES PROVIDED BY THE HOSPITAL; HOWEVER, THE IMAGES FAILED TO RUN PROPERLY. AN IMAGING REVIEW COULD NOT BE CONDUCTED FOR THE REPORTED EVENT. THE EXACT ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. HOWEVER, THIS PATIENT WAS NOTED TO HAVE CALCIUM DISTRIBUTION ON THE LEAFLETS AND NOT ON THE ANNULUS, LOW POSITIONING OF THE FIRST VALVE, AND REPORTED FAIR COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM. THESE PATIENT AND PROCEDURAL FACTORS COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PER THE EDWARDS SAPIEN VALVE INSTRUCTIONS FOR USE (IFU) AND THE THV TRAINING GUIDE, 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 AORTIC MALPOSITION AND/OR EMBOLIZATION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE (IIA), POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMAL VALVE CALCIFICATION, AND LOSS OF PACING CAPTURE. PROCEDURAL TRAINING 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 ALSO 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 ADDITION THE PHYSICIANS ARE TRAINED TO VERIFY POST DEPLOYMENT POSITION OF THE PROSTHETIC VALVE TO ASSESS FOR BALLOON DILATATION REQUIREMENT. THE TRAINING MANUALS STATE THAT SOME PVL IS EXPECTED POST DEPLOYMENT AND TO CONSIDER REPEAT BALLOON EXPANSION IF THE PVL IS SEVERE.

    Additional Manufacturer Narrative · 1

    THIS PATIENT WAS NOTED TO HAVE CALCIFIED LEAFLETS. THE PATIENT DID NOT HAVE A CALCIFIED STJ, AND SEVERE VENTRICULAR SEPTAL HYPERTROPHY. THERE WAS NOTED FAIR COAXIAL ALIGNMENT, OF THE VALVE AND THE DELIVERY SYSTEM. DURING DEPLOYMENT OF THE FIRST SAPIEN VALVE BALLOON INFLATION WAS HELD FOR 3 SECONDS, VENTILATION WAS HELD, AND THERE WAS NO LOSS OF PACING CAPTURE DURING DEPLOYMENT OF THE FIRST VALVE. IN THIS CASE, THE FLUORO IMAGERY WAS CUT OFF DURING DEPLOYMENT OF THE FIRST VALVE AND THE MOVEMENT OF THE VALVE WAS NOT NOTICED. THE EXACT ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION AT THIS TIME. FOLLOW UP ATTEMPTS FOR THE ECHO IMAGERY FROM THE HOSPITAL ARE IN PROGRESS AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED VIA THE EDWARDS CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER HEART VALVE REPLACEMENT (TAVR) PROCEDURE, THE FIRST EDWARDS SAPIEN VALVE EMBOLIZED INTO THE VENTRICLE. A SECOND SAPIEN VALVE WAS PLACED IN THE CORRECT POSITION WITHIN THE ANNULUS. THE EMBOLIZED VALVE WAS EXPLANTED VIA A RIGHT THORACTOMY. ACCORDING TO THE CASE SUMMARY THE FIRST EDWARDS SAPIEN VALVE WAS POSITIONED 50:50. DURING DEPLOYMENT THE VALVE MOVED SLIGHTLY VENTRICULAR. THE MOVEMENT WAS NOT NOTICED DUE TO THE FLUORO IMAGING CUTTING OFF DURING MID DEPLOYMENT. THE FINAL POSITION OF THE VALVE WAS DETERMINED TO BE ACCEPTABLE VIA ECHO. THE POSITION APPEARED TO BE 40% AORTIC AND 60% VENTRICULAR. MILD TO MODERATE POSTERIOR PARAVALVULAR LEAK (PVL) WAS NOTED. A DECISION WAS MADE TO POST DILATE WITH AN EXTRA 0.5ML ADDED TO THE SYSTEM. THE VALVE WAS POST DILATED AND THE LEAK WAS REDUCED TO ZERO. AFTER THE WIRE WAS REMOVED THE VALVE WAS NOTED TO BE IN A MORE VENTRICULAR POSITION. THE WIRE ACCESS WAS REGAINED THROUGH THE VALVE. A 26MM VALVULOPLASTY BALLOON WAS INFLATED DURING RAPID PACING AND MANIPULATED MORE AORTIC IN AN ATTEMPT TO MOVE THE VALVE MORE AORTIC. A SECOND SAPIEN VALVE WAS PREPPED AND INTRODUCED INTO THE BODY. WHILE ATTEMPTING TO CROSS THE FIRST VALVE WITH THE DELIVERY SYSTEM THE FIRST SAPIEN VALVE WAS DISLODGED TOWARDS THE VENTRICLE. THE SECOND VALVE WAS DEPLOYED IN THE CORRECT POSITION WITH MILD PVL. THE PATIENT REMAINED STABLE THROUGHOUT THE ENTIRE PROCEDURE. THE GROIN INCISION WAS CLOSED AND THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR REMOVAL OF THE FIST VALVE. THE FIRST VALVE WAS EXPLANTED VIA A RIGHT THORACOTOMY BY ACCESSING THE LEFT ATRIUM. THE VALVE WAS CRUSHED WITH HEMOSTATS AND REMOVED THROUGH THE MITRAL VALVE. AFTER EXPLANTING THE VALVE THE PATIENT WENT INTO RIGHT HEART FAILURE. THE PATIENT WAS TRANSFERRED TO THE ICU IN A CRITICAL CONDITION. ONE DAY S/P TAVR THE PATIENT WAS STILL NOTED TO BE IN A CRITICAL CONDITION WITH LITTLE TO NO IMPROVEMENT OF THE RIGHT VENTRICLE. THE AORTIC VALVE WAS NOTED TO BE IN GOOD POSITION WITH TRACE TO ZERO PVL. THE PATIENT EXPIRED TWO DAYS S/P TAVR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SAPIEN TRANSCATHETER HEART VALVE TISSUE, HEART-VALVE LWR EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention