BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3090439 · Received May 2, 2013

    Report

    Report Number
    2015691-2013-19973
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE SITE. IN ADDITION, THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. PER THE INSTRUCTIONS FOR USE (IFU), DEVICE EMBOLIZATION 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 EMBOLIZATION, 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 EMBOLIZATION (I.E. SMALL, CALCIFIED STJ, MINIMAL LEAFLET CALCIFICATION), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. IN THIS CASE, PER REPORT, THE MEDICAL TEAM FELT THAT THE SEVERE CALCIFICATION ON THE NATIVE VALVE AND ROOT CAUSED THE VALVE TO MOVE VENTRICULAR UPON DEPLOYMENT. IN ADDITION, THE FAIR COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM MAY HAVE ALSO CONTRIBUTED TO THE EVENT. 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 THE EDWARDS FIELD CLINICAL SPECIALIST, THE 23MM SAPIEN VALVE EMBOLIZED INTO THE LEFT VENTRICLE UPON DEFLATION OF THE DELIVERY BALLOON. CASE SUMMARY: THE PATIENT HAD A 90% LEFT MAIN LESION THAT WAS DISCOVERED DURING WORKUP FOR THE TAVR PROCEDURE. DUE TO LOWER THAN NORMAL EJECTION FRACTION (40%) AND THE LEFT MAIN LESION, THE PHYSICIANS DECIDED TO STENT THE LEFT MAIN PRE-PROCEDURE WITH TANDEM HEART SUPPORT. PROCEDURAL TEE WAS COMPLETED AND A MEASUREMENT OF 22MM WAS OBTAINED FOR THE NATIVE AORTIC ANNULUS. A 23MM VALVE WAS SELECTED BASED ON THIS ANALYSIS. CANNULAS WERE PLACED FOR TANDEM HEART AND THE LEFT MAIN WAS SUCCESSFULLY STENTED WITHOUT INCIDENT. THE WIRE AND BALLOON WERE LEFT IN LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AS THE PHYSICIANS WERE CONCERNED ABOUT DISTANCE BETWEEN THE ANNULUS AND THE CORONARY OSTIA. THE 23MM SAPIEN VALVE WAS ADVANCED ACROSS THE NATIVE AORTIC ANNULUS VIA A TRANSFEMORAL APPROACH WITHOUT ISSUE. RAPID VENTRICULAR PACING (RVP) WAS INITIATED, WITH CAPTURE AND PRESSURE AT APPROPRIATE LEVELS. THE SAPIEN VALVE WAS THEN POSITIONED IN A 60:40 VENTRICULAR POSITION. DURING DEPLOYMENT, THE VALVE MOVED TOWARD THE VENTRICLE. AS THE DELIVERY BALLOON WAS DEFLATED THE SAPIEN VALVE EMBOLIZED INTO THE LEFT VENTRICLE. GUIDEWIRE POSITION WAS MAINTAINED AND A SECOND SAPIEN VALVE WAS ADVANCED ACROSS THE ANNULUS AND POSITIONED 50:50. RVP WAS INITIATED AND THE DELIVERY BALLOON WAS INFLATED IN A SLOWER FASHION THAN THE FIRST VALVE. THE SAPIEN IMMEDIATELY BEGAN MOVING VENTRICULAR, SO THE INFLATION WAS STOPPED AND THE VALVE WAS PULLED BACK AND REPOSITIONED. THE VALVE MOVED INTO THE AORTA AND WAS THEN RE-ADVANCED ACROSS THE NATIVE AORTIC VALVE. THE VALVE WAS THEN SUCCESSFULLY DEPLOYED AND REMAINED IN A 50:50 POSITION. THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS (CPB) AND THE SURGEONS REMOVED THE EMBOLIZED VALVE THRU AN INCISION IN THE LEFT VENTRICLE. THE PATIENT WAS WEANED FROM CPB WITH NO ADDITIONAL COMPLICATIONS. THE PATIENT REMAINED STABLE AND WAS TRANSPORTED TO THE INTENSIVE CARE UNIT (ICU) FOR RECOVERY. THE NATIVE AORTIC ANNULUS MEASURED 21MM BY TEE, 19MM BY TTE, AND 19.9X26.9 (AREA 427) BY CT, WITH A MEAN OF 23.4MM. THE NATIVE AORTIC VALVE AND ROOT WERE BOTH SEVERELY CALCIFIED. THE SINOTUBULAR JUNCTION (STJ) HAD A DIAMETER OF 27.5MM. DURING VALVE DEPLOYMENT, VENTILATION WAS HELD, AND THERE WAS NO LOSS OF PACING CAPTURE. THE IMAGE INTENSIFIER ANGLE WAS DESCRIBED AS GOOD, AND THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WAS DESCRIBED AS FAIR. PER REPORT, THE MEDICAL TEAM FELT THAT THE SEVERE CALCIFICATION ON THE NATIVE VALVE AND ROOT CAUSED THE VALVE TO MOVE VENTRICULAR UPON DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193110 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention