BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3071148 · Received April 22, 2013

    Report

    Report Number
    2015691-2013-19873
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 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, DEVICE MALPOSITION REQUIRING INTERVENTION AND VALVE REGURGITATION ARE POTENTIAL ADVERSE EVENTS 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, 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 AND ANATOMICAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (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. ALTHOUGH IT CANNOT BE CONFIRMED, IT APPEARS THAT THE CAI WAS LIKELY CAUSED BY THE INTENDED 90:10 AORTIC PLACEMENT OF THE SAPIEN VALVE, WHICH MAY HAVE LED TO A FLARING OF THE OUTFLOW PORTION OF THE VALVE FRAME. 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, A 23MM SAPIEN VALVE WAS POSITIONED AND DEPLOYED 90:10 AORTIC, RESULTING IN 2+ CENTRAL AORTIC INSUFFICIENCY (CAI). A SECOND SAPIEN VALVE WAS POSITIONED 70:30 AORTIC. POST DEPLOYMENT, THE SECOND SAPIEN VALVE¿S POSITION WAS 60:40 AORTIC AND THE CAI RESOLVED. THE PATIENT WAS NOTED TO BE IN STABLE CONDITION POST TAVR. THE NATIVE ANNULAR DIAMETER WAS 19MM BY TEE. THE NATIVE AORTIC VALVE WAS SEVERELY CALCIFIED. THERE WAS MODERATE MITRAL ANNULAR CALCIFICATION (MAC) AND NO VENTRICULAR SEPTAL HYPERTROPHY. THE PATIENT'S EJECTION FRACTION (EF) WAS 35-40%. THE IMAGE INTENSIFIER ANGLE AND THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WERE BOTH DESCRIBED AS GOOD. THE SAPIEN VALVE WAS INTENTIONALLY POSITIONED AND IMPLANTED IN A 90:10 AORTIC POSITION DUE TO THE SITE'S PREFERENCE FOR IMPLANTING VALVES IN A MORE AORTIC POSITION. PER REPORT, THERE APPEARED TO BE A FLARING OF THE FIRST SAPIEN VALVE, POTENTIALLY CAUSING THE LEAFLETS TO NOT COAPT CORRECTLY, ALTHOUGH THIS WAS NOT CONFIRMED ON TEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172706 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention