BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3053020 · Received April 11, 2013

    Report

    Report Number
    2015691-2013-19795
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTIONS FOR USE (IFU), VALVE REGURGITATION AND DEVICE MALPOSITION REQUIRING INTERVENTION ARE KNOWN POTENTIAL COMPLICATIONS 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 VENTRICULAR MALPOSITION AND/OR EMBOLIZATION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, A NARROW, CALCIFIED SINOTUBULAR JUNCTION, MINIMAL VALVE CALCIFICATION, AND LOSS OF PACING CAPTURE. THE EDWARDS TRANSFEMORAL DELIVERY SYSTEM 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 ADDITION, THE PATIENT SCREENING MANUAL AND THE PROCEDURE DIDACTIC IDENTIFY SEVERAL PROCEDURAL AND ANATOMICAL FACTORS WHICH COULD CONTRIBUTE TO PARAVALVULAR LEAK, INCLUDING DEVICE MALPOSITIONING, INACCURATE MEASUREMENT OF THE NATIVE VALVE ANNULUS, IMPROPER VALVE SIZING, AND UNEVEN DISTRIBUTION OF CALCIUM ON THE NATIVE VALVE. ALTHOUGH IT CANNOT BE CONFIRMED, IT IS POSSIBLE THAT PATIENT FACTORS, SUCH AS MODERATE BULKY CALCIFICATION OF THE NATIVE VALVE MAY HAVE CONTRIBUTED TO THE VENTRICULAR SHIFT OF THE VALVE UPON DEPLOYMENT. THE PVL WAS LIKELY CAUSED BY A COMBINATION OF BULKY NATIVE VALVE CALCIFICATION AND THE 70:30 VENTRICULAR PLACEMENT OF THE VALVE. 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, DURING A TRANSAPICAL TAVR PROCEDURE THE 26MM SAPIEN VALVE SHIFTED VENTRICULAR UPON DEPLOYMENT, RESULTING IN 70:30 VENTRICULAR PLACEMENT OF THE VALVE AND 2+ PARAVALVULAR LEAK. SUBSEQUENTLY A SECOND 26MM SAPIEN VALVE WAS IMPLANTED MORE AORTIC WITHIN THE FIRST VALVE. THE PATIENT WAS STABLE AND THE NEW VALVE WAS NOTED TO BE WORKING WELL POST PROCEDURE.THE NATIVE AORTIC ANNULAR DIAMETER WAS 23.5MM BY TEE. THERE WAS MODERATE, BULKY CALCIFICATION ON THE NATIVE AORTIC VALVE. THE AORTIC ROOT AND SINOTUBULAR JUNCTION (STJ) WERE MILDLY CALCIFIED. THE PATIENT¿S EJECTION FRACTION (EF) WAS 55%. THE IMAGE INTENSIFIER ANGLE AND COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WERE BOTH DESCRIBED AS GOOD. DURING VALVE DEPLOYMENT, VENTILATION WAS HELD AND THERE WAS NO LOSS OF PACING CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155672 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention