BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3103343 · Received May 9, 2013

    Report

    Report Number
    2015691-2013-20043
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, DEVICE MALPOSITION AND REGURGITATION REQUIRING INTERVENTION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE 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. IN THIS CASE, THE ROOT CAUSE OF THE MALPOSTION APPEARS TO BE FORWARD PRESSURE ON THE DELIVERY SYSTEM BY THE PHYSICIAN TO AVOID CONTACT WITH THE SEPTAL HYPERTROPHY. THE PATIENT'S PRESERVED EJECTION FRACTION COULD ALSO HAVE CONTRIBUTED TO THE MALPOSITION. 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; THEREFORE NO FURTHER ACTIONS ARE REQUIRED. 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.

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TAVR PROCEDURE, THE VALVE WAS DEPLOYED IN AN 80/20 AORTIC POSITION WITH MODERATE/SEVERE CAI. A SECOND VALVE WAS PLACED. ADDITIONAL INFORMATION REVEALED THAT THE INITIAL PLACEMENT OF THE FIRST VALVE WAS APPROXIMATELY 60:40 (AORTIC).IT WAS NOTED PRIOR TO THE CASE THAT THERE WAS MODERATE SEPTAL HYPERTROPHY SO THE OPERATOR TRIED TO PUT FORWARD PRESSURE ON THE DELIVERY SYSTEM AS THE VALVE WAS DELIVERED. THE VALVE ENDED UP IN AN 80:20 AORTIC POSITION. A SECOND SAPIEN VALVE WAS IMPLANTED MORE VENTRICULAR, SEATING ROUGHLY 60/40 IN THE ANNULUS. PT LEFT THE ROOM IN STABLE CONDITION. ADDITIONAL INFORMATION REVEALED THE PATIENT HAD MODERATE VALVE/LEAFLET CALCIFICATION, AND MILD AORTIC ROOT CALCIFICATION. THE PATIENT'S EJECTION FRACTION WAS 65%. THERE WAS GOOD COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, AND GOOD IMAGE INTENSIFIER ANGLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203900 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention