BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2922627 · Received January 18, 2013

    Report

    Report Number
    2015691-2013-19145
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MANUFACTURING REPORT NUMBER 2015691-2013-19144 FOR THE FIRST VALVE IMPLANTED IN THIS CASE. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE IMAGING FROM THE PROCEDURE COULD NOT BE OBTAINED FOR REVIEW. HOWEVER, PER REPORT, THE FCS AND HOSPITAL STAFF DISCUSSED THE PROCEDURE AND REVIEWED THE FILMS AT LENGTH. IT WAS DETERMINED THAT TWO FACTORS LIKELY COMBINED TO CAUSE THE EVENT: AFTER THE FIRST SAPIEN VALVE WAS POSITIONED ACROSS THE NATIVE ANNULUS, THE OPERATOR PULLED BACK THE PIGTAIL CATHETER, WHICH CREATED TENSION AND CAUSED THE VALVE TO MOVE AORTIC. THE OPERATOR DID NOT RE-CHECK THE POSITION OF THE SAPIEN VALVE AFTER MOVING THE PIGTAIL CATHETER. THE PATIENT'S LEFT VENTRICLE WAS SMALL AND HYPERDYNAMIC, WHICH CAUSED A "WATERMELON SEEDING" OF THE VALVE AORTIC WHEN THE BALLOON WAS FULLY INFLATED. PER THE FCS, THE MOVEMENT OF THE VALVE DID NOT OCCUR UNTIL AFTER THE BALLOON WAS FULLY INFLATED, VERIFYING THIS FACTOR. PER THE SAPIEN VALVE INSTRUCTIONS FOR USE (IFU) AND THE TRANSCATHETER HEART VALVE (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, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, 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 REPORT, IT APPEARS THAT A COMBINATION OF PROCEDURAL FACTORS (NOT VERIFYING VALVE POSITIONING FOLLOWING WITHDRAWAL OF THE PIGTAIL CATHETER) AND PATIENT FACTORS (SMALL, HYPER-DYNAMIC LEFT VENTRICLE) CONTRIBUTED TO THE AORTIC MALPOSITION. THE REPORTED LOSS OF PACING CAPTURE DURING DEPLOYMENT OF THE SECOND SAPIEN VALVE CAUSED BOTH VALVES TO EMBOLIZE AORTIC. 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 (FCS), THE 23MM SAPIEN VALVE WAS POSITIONED 50:50 IN THE NATIVE AORTIC ANNULUS. DURING DEPLOYMENT THE VALVE MOVED AORTIC, RESULTING IN A LOSS OF PLACEMENT WITHIN THE NATIVE ANNULUS. THE VALVE WAS HELD IN PLACE BY THE NATIVE AORTIC LEAFLETS. A SECOND SAPIEN VALVE WAS PREPPED AND POSITIONED WITHIN THE NATIVE AORTIC ANNULUS AND DEPLOYED IN A POSITION THAT ALSO ALLOWED FOR IT TO OVERLAP AND ANCHOR THE FIRST SAPIEN IN PLACE. HOWEVER, PACING CAPTURE WAS LOST PRIOR TO FULL DEFLATION OF THE DELIVERY BALLOON, CAUSING BOTH SAPIEN VALVES TO EMBOLIZE AORTIC. A THIRD SAPIEN VALVE WAS PREPPED AND SUCCESSFULLY IMPLANTED WITHIN THE NATIVE ANNULUS. POST PROCEDURE, THE PATIENT DEMONSTRATED NORMAL LEFT VENTRICULAR FUNCTION AND NORMAL CORONARY FLOW. AS OF 48 HOURS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), THE PATIENT CONTINUED TO DEMONSTRATE NORMAL LEFT VENTRICULAR FUNCTION AND NORMAL CORONARY FLOW. ADDITIONAL INVESTIGATION REVEALED THE FOLLOWING: THE FINAL LOCATION OF THE THREE VALVES IMPLANTED IN THIS PATIENT ARE AS FOLLOWS: THE 3RD DEPLOYED VALVE IS IN THE NATIVE AORTIC ANNULUS, THE SECOND VALVE IS PINNED TO THE SINOTUBULAR JUNCTION (STJ), AND THE FIRST VALVE IS IN THE ASCENDING AORTA. ALL OF THE VALVE FRAMES ARE CONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27732 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23 3042824

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention