BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3130888 · Received May 24, 2013

    Report

    Report Number
    2015691-2013-20174
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS ONGOING.

    Additional Manufacturer Narrative · 1

    CINE AND TEE IMAGES OF THE PROCEDURE WERE PROVIDED TO EDWARDS BY THE FACILITY FOR INTERNAL REVIEW. THE IMAGES WERE REVIEWED BY AN EDWARDS¿S PHYSICIAN AND THE FOLLOWING OBSERVATIONS WERE MADE: OBSERVATIONS: SEVERE AORTIC VALVE CALCIFICATION, SEVERE AORTIC ROOT CALCIFICATION, NO PORCELAIN AORTA, NO MITRAL ANNULAR CALCIFICATION (MAC). "WAIST" NOTED DURING BAV. FAIR COAXIAL ALIGNMENT OF VALVE AND DELIVERY SYSTEM. FAIR IMAGE INTENSIFIER ANGLE (IIA). WIRE PLACED DOWN LAD PRIOR TO DEPLOYMENT OF VALVE. POSITION OF VALVE PRE-DEPLOYMENT WAS CANTED, 35/65 VENTRICULAR LATERALLY, AND 20/80 VENTRICULAR MEDIALLY. NO MOVEMENT OF VALVE DURING DEPLOYMENT; HOWEVER, THERE WAS SIGNIFICANT RECOIL OF THE OUTFLOW OF THE VALVE POST DEPLOYMENT. POST DEPLOYMENT AORTOGRAM DEMONSTRATES AORTIC REGURGITATION (AR). IMPRESSIONS: VALVE POSITION CANTED AND SIGNIFICANTLY VENTRICULAR IN THE PRESENCE OF SEVERE VALVULAR CALCIFICATION. CONSEQUENTLY, THE AORTIC EDGE OF THE VALVE FAILED TO FULLY EXPAND. THIS LED TO THE SUBSEQUENT LV EMBOLIZATION. PER THE INSTRUCTIONS FOR USE (IFU), DEVICE MALPOSITION REQUIRING INTERVENTION IS A KNOWN POTENTIAL COMPLICATION 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 VENTRICULAR MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, A NARROW, CALCIFIED SINOTUBULAR JUNCTION, MINIMALLY CALCIFIED AORTIC LEAFLETS, 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 VENTRICULAR MALPOSITION (I.E. SMALL, CALCIFIED STJ, MINIMAL LEAFLET CALCIFICATION), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. IN THIS CASE, IT APPEARS THAT THE REPORTED ASYMMETRICAL DEPLOYMENT AND LV EMBOLIZATION OF THE SAPIEN VALVE WERE RELATED TO A COMBINATION OF PATIENT AND PROCEDURAL FACTORS. ACCORDING TO THE SURGEON THE NATIVE AORTIC VALVE WAS TRI-LEAFLET, BUT THE VALVE LEAFLETS WERE SEVERELY FUSED AT EACH COMMISSURE. UPON REVIEW OF ECHO/FLUORO FROM THE TAVI PROCEDURE IT WAS NOTED THAT THE SAPIEN VALVE WAS POSITIONED CANTED AND TOO VENTRICULAR PRIOR TO DEPLOYMENT IN THE PRESENCE OF SEVERE AORTIC VALVE CALCIFICATION. CONSEQUENTLY, THE AORTIC EDGE OF THE VALVE FAILED TO FULLY EXPAND, LEADING TO THE SUBSEQUENT VALVE EMBOLIZATION TO THE LV. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION, AS IT WAS CRUSHED DURING EXPLANT AND DISCARDED BY THE PHYSICIAN. THE EVENT WAS NOT CONSIDERED TO BE RELATED TO A MALFUNCTION 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

    PER THE EDWARDS LIFESCIENCES CLINICAL SPECIALIST REPORT, DURING A TRANSFEMORAL TAVR PROCEDURE POST DEPLOYMENT THE 26 MM SAPIEN VALVE WAS SMALLER ON THE AORTA SIDE AND EXPANDED MORE HEAVILY ON THE VENTRICLE SIDE, APPEARING RHOMBOID IN NATURE. DURING BALLOON INFLATION THE VALVE REMAINED IN ANNULUS WITH NO AORTIC INSUFFICIENCY (AI) NOTED FROM ECHO. SINCE THERE WAS NO AI ON ECHO IT WAS DETERMINED NOT TO PROCEED WITH FURTHER INTERVENTION. APPROXIMATELY 3 MINUTES POST VALVE DEPLOYMENT, A ROOT SHOT WAS PERFORMED AND THE VALVE APPEARED TO BE SLIGHTLY TILTED WITH ONE SIDE APPEARING TO HAVE SHIFTED IN THE VENTRICLE. THE AI WAS MUCH WORSE ON THE ROOT SHOT AND THE REPEAT ECHO CONFIRMED SEVERE AI. MOMENTS LATER THE VALVE TUMBLED INTO THE VENTRICLE. THE PATIENT WAS PLACED ON BYPASS AND FOLLOWED UP WITH STERNOTOMY FOR THE SAPIEN VALVE REMOVAL AND AVR. A 23 MM SURGICAL VALVE WAS INSERTED; THE SURGEON DETERMINED THAT THE VALVE WAS TRI-LEAFLET, BUT THE VALVE LEAFLETS WERE SEVERELY FUSED AT EACH COMMISSURE. THE PATIENT WAS STABLE POST OP. IT WAS DISCUSSED DURING A POST-BRIEF THAT THE RESISTANCE OF THE FUSED LEAFLETS CAUSED A LOT OF RESISTANCE WITH THE BAV AND DID NOT ALLOW FULL EXPANSION OF THE VALVE ON THE AORTIC SIDE, AS THERE WAS ALSO VALVE RECOIL NOTED ON POST-REVIEW PICTURES. THIS ALONG WITH THE SEVERE BULKY CALCIFIED LEAFLETS ALLOWED THE VALVE TO SLIP IN THE VENTRICLE. PER REPORT: THE AORTIC ANNULUS DIAMETER MEASURED 20.6 X 27.6 MM PER CT. THE DEGREE OF CALCIFICATION WAS CONSIDERED TO BE SEVERE FOR THE AORTIC VALVE LEAFLETS, MILD FOR THE AORTIC ROOT AND NONE FOR THE MITRAL VALVE ANNULUS. THE LEFT VENTRICULAR EJECTION FRACTION WAS 25%. THE COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND VALVE, AND THE IMAGE INTENSIFIER ANGLE, WERE REPORTED AS FAIR. THERE WERE NO ISSUES WITH THE PACING CAPTURE AND THE PATIENT¿S VENTILATION WAS HELD DURING DEPLOYMENT. POST DEPLOYMENT THE SAPIEN VALVE POSITION WAS 60:40 VENTRICULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231432 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention