BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2962622 · Received February 14, 2013

    Report

    Report Number
    2015691-2013-19286
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT; HOWEVER, THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. PER THE DEVICE INSTRUCTIONS FOR USE (IFU), DEVICE MALPOSITION REQUIRING INTERVENTION AND VALVE REGURGITATION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSAORTIC HEART 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 AORTIC MALPOSITION, 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 APPEARS THAT THE FINAL POSITION OF THE VALVE WAS RELATED TO PROCEDURAL FACTORS. IT WAS REPORTED THAT THERE WAS "SOME CONFUSION" AT THE POINT OF DEPLOYMENT, AND THE SAPIEN WAS DEPLOYED 2-3MM LOWER THAN INITIAL PLAN. 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 REPORT BY THE EDWARDS CLINICAL SPECIALIST, THE INITIAL 23MM SAPIEN VALVE WAS IMPLANTED TOO LOW AND REQUIRED IMPLANTATION OF A SECOND VALVE. THE PLAN WAS TO LAND THE 23MM SAPIEN VALVE 60/40 INSIDE OF THE EXISTING/FAILED HANCOCK-2 VALVE. HOWEVER, THERE WAS SOME CONFUSION AT THE POINT OF DEPLOYMENT, AND THE SAPIEN WAS DEPLOYED 2-3MM LOWER THAN INITIAL PLAN. AS A RESULT, THERE WAS SOME PARAVALVULAR LEAK (PVL). THE TEAM OPTED TO PLACE A SECOND 23MM SAPIEN VALVE INSIDE THE FIRST SAPIEN VALVE IMPLANTED. THIS WORKED PERFECTLY. LASTLY, THE TEAM PLACED AN AMPLATZER PLUG IN THE PVL SPOT THAT WAS LOCATED OUTSIDE OF THE SEWING RING OF THE HANCOCK-2. THE END RESULT WAS ZERO PVL AND A FULLY FUNCTIONING SAPIEN. THE "PATIENT DID GREAT" AND WAS STABLE AFTER THE PROCEDURE. ADDITIONAL INFORMATION REVEALED THE PATIENT'S AORTIC VALVE ANNULUS MEASURED 18MM BY TEE, WITH SEVERE LEAFLET CALCIFICATION. THE SINOTUBULAR JUNCTION DIAMETER MEASURED 24MM. THE PATIENT HAD A BASELINE EJECTION FRACTION OF 30%. THERE WAS MODERATE MITRAL ANNULAR CALCIFICATION AND NO VENTRICULAR SEPTAL HYPERTROPHY. THERE WERE GOOD IMAGING INTENSIFIER ANGLE AND GOOD COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM/VALVE IN RESPECT WITH THE AORTIC ANNULUS. THERE WAS NO LOSS OF PACING CAPTURE DURING VALVE DEPLOYMENT, AND THE PATIENT'S VENTILATION WAS HELD FOR THE RECOMMENDED AMOUNT OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64903 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention