BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3040296 · Received April 8, 2013

    Report

    Report Number
    2015691-2013-19755
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT; HOWEVER, PER REPORT THE EVENT WAS NOT CAUSED BY A MALFUNCTION OF THE VALVE. PER THE DEVICE INSTRUCTIONS FOR USE (IFU), DEVICE MALPOSITION REQUIRING INTERVENTION AND TRANSVALVULAR LEAK ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. 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 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. THERE ARE SEVERAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO AN INADEQUATE VALVE POSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, AND POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMAL VALVE CALCIFICATION, AND LOSS OF PACING CAPTURE. IN THIS CASE IT CANNOT BE CONFIRMED WHAT CAUSED THE SAPIEN VALVE TO BE IMPLANTED TOO LOW WITH SUBSEQUENT CAI; HOWEVER, IT APPEARS THAT THE FINAL POSITION OF THE VALVE WAS RELATED TO PROCEDURAL FACTORS. PER REPORT, THE COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM WITH THE ANNULUS WAS ONLY FAIR AND THE IMAGING INTENSIFIER ANGLE WAS POOR. IT APPEARS THAT THESE PROCEDURAL FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE VALVE BEING DEPLOYED TOO LOW WHICH LED TO NATIVE LEAFLET OVERHANG. AN OVERHANGING LEAFLET CAN INTERFERE WITH THE NORMAL CLOSING OF THE BIOPROSTHESIS DURING RETROGRADE BLOOD FLOW IN DIASTOLE. THE IFU AND EDWARDS THV PATIENT SCREENING 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 PREVENTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    PER THE EDWARDS LIFESCIENCES CLINICAL SPECIALIST REPORT, IN A TRANSAPICAL TAVR CASE THE 26MM SAPIEN VALVE WAS IMPLANTED TO VENTRICULAR CAUSING MODERATE CENTRAL AORTIC INSUFFICIENCY (CAI) BECAUSE OF THE NATIVE LEAFLET OVERHANG. A 2ND 26MM SAPIEN VALVE WAS IMPLANTED IN A MORE AORTIC POSITION WITH NO LEAKS. THE PATIENT WAS RETURNED TO THE RECOVERY UNIT IN STABLE CONDITION. PER REPORT: THE DEGREE OF CALCIFICATION WAS CONSIDERED MODERATE FOR THE AORTIC VALVE LEAFLETS, MILD FOR THE AORTIC ROOT AND THE MITRAL VALVE ANNULUS WAS MODERATELY CALCIFIED. THE LV EF WAS 60%. THE COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM WITH THE ANNULUS WAS CONSIDERED TO BE ONLY FAIR AND IMAGE INTENSIFIER ANGLE WAS DESCRIBED AS POOR. THERE WERE NO ISSUES WITH THE PACING CAPTURE AND THE PATIENT'S VENTILATION WAS HELD DURING DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142585 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention