BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3801182 · Received May 8, 2014

    Report

    Report Number
    2015691-2014-01080
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    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

    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, AS REPORTED, THE CAUSE OF THE EMBOLIZATION OF THE SAPIEN VALVE INTO THE VENTRICLE WAS THE OPERATOR OVERCOMPENSATING WHILE REPOSITIONING THE VALVE DURING DEPLOYMENT.THE CAUSE FOR THE INTRA-CARDIAC THROMBUS CANNOT BE DETERMINED 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

    IT WAS REPORTED THAT DURING THE TRANSAPICAL DEPLOYMENT OF A 23MM SAPIEN VALVE, THE VALVE EMBOLIZED INTO THE VENTRICLE. THE SAPIEN VALVE WAS POSITIONED 50:50 IN THE NATIVE ANNULUS AND DURING THE TWO STEP DEPLOYMENT THE VALVE STARTED TO RISE AORTIC. AT THIS TIME, THE OPERATOR OVERCOMPENSATED AND PULLED THE VALVE VENTRICULAR, CAUSING THE VALVE TO EMBOLIZE INTO THE LEFT VENTRICLE. THE PATIENT WAS STABLE AT THIS POINT AND THE VALVE AND DELIVERY DEVICE WERE PULLED TO THE TIP OF THE SHEATH WHILE MAINTAINING GUIDEWIRE POSITION. THE SURGICAL TEAM DECIDED NOT TO PUT THE PATIENT ON CARDIOPULMONARY BYPASS, AND ATTEMPTED TO REMOVE THE VALVE, REPAIR THE APEX, AND INSERT ANOTHER SAPIEN VALVE THROUGH THE APEX. THE PATIENT CODED RIGHT BEFORE THE VALVE WAS REMOVED FROM THE VENTRICLE. THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VF) AND WAS DEFIBRILLATED MULTIPLE TIMES. CPR WAS INITIATED AND AN INTRA-AORTIC BALLOON PUMP (IABP) WAS PLACED. THE PATIENT¿S RHYTHM STABILIZED ONCE THE VALVE AND THE GUIDEWIRE WERE REMOVED; THE APEX WAS REPAIRED AT THIS TIME. THE IABP HAD GOOD AUGMENTATION AND THE PATIENT¿S PRESSURE WAS STILL BEING SUPPORTED BY THE IABP AND MEDICATION. A SECOND VALVE WAS PREPPED, THE APEX WAS RE-ACCESSED, AND A NEW SHEATH WAS INSERTED. THE SECOND DELIVERY SYSTEM AND VALVE WERE INSERTED WITH SUCCESSFUL DEPLOYMENT INTO THE NATIVE ANNULUS. ECHO SHOWED TRACE PVL AND THE PATIENT REMAINED STABLE; PROTAMINE WAS GIVEN AND APICAL CLOSURE WAS INITIATED. AT THIS TIME, THROMBUS WAS NOTED IN THE LEFT ATRIUM AND LEFT VENTRICLE ON ECHO. THE THROMBUS CONTINUALLY INCREASED AND THE PATIENT BEGAN TO CODE AGAIN. THE PATIENT WAS GIVEN 20,000 UNITS OF HEPARIN AND LIGHT CPR WAS INITIATED. TPA WAS THEN ADMINISTERED FOR THE THROMBUS. AN ACTIVE CODE WAS RAN FOR AN HOUR AND A HALF. THE PATIENT WENT IN AND OUT OF VF AND WAS DEFIBRILLATED MULTIPLE TIMES. CPR WAS STOPPED AND THE IABP WAS SUSPENDED TO ASSESS THE PATIENT¿S PRESSURE AND RHYTHM. DESPITE EFFORTS THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278512 SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| R