BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2901122 · Received January 8, 2013

    Report

    Report Number
    2015691-2013-19031
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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 KNOWN 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 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. PER REPORT, INFLATION OF THE VALVE PROSTHESIS OCCURRED TOO FAST, AND THE PHYSICIANS COULD NOT GET THE WIRE OUT OF THE COMMISSURE OF THE NC CUSP, CONTRIBUTING TO THE AORTIC MOVEMENT OF THE VALVE. THE FINAL 70:30 AORTIC POSITION OF THE VALVE, IN COMBINATION WITH SEVERE NATIVE VALVE CALCIFICATION, LIKELY RESULTED IN THE REPORTED SEVERE PVL AND MODERATE AI.

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE VALVE MOVED TOO AORTIC, CAUSING MODERATE CENTRAL AI AND SEVERE PARAVALVULAR LEAK (PVL). ADDITIONAL INFORMATION REVEALED THE FOLLOWING: THE AORTIC ROOT WAS MODERATELY CALCIFIED AND THE NATIVE LEAFLETS HAD BULKY CALCIFICATION. THE PATIENT'S LEFT VENTRICULAR EJECTION FRACTION WAS 60%. A 23 MM VALVE WAS POSITIONED 50:50. THE IMAGE INTENSIFIER ANGLE WAS DESCRIBED AS GOOD, AND THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WERE ALSO DESCRIBED AS GOOD. THE VALVE WAS INFLATED AND DURING INFLATION MOVED 70:30 AORTIC. DURING DEPLOYMENT, VENTILATION WAS HELD, BALLOON INFLATION WAS HELD FOR THREE OR MORE SECONDS, AND PACING CAPTURE WAS NOT LOST; HOWEVER, PER REPORT, THE INFLATION OCCURRED TOO FAST AND THE PHYSICIANS COULD NOT GET THE WIRE OUT OF THE COMMISSURE OF THE NC CUSP. UPON ANALYZING THE ECHO IT WAS OBSERVED THAT THERE WAS SEVERE PVL AND MODERATE CENTRAL AI. A SECOND 23 MM VALVE WAS PREPPED AND POSITIONED 2 MM LOWER THAN THE ORIGINAL VALVE. THE VALVE WAS SUCCESSFULLY IMPLANTED, WITH NO CENTRAL LEAK AND THE FINAL PVL WAS MODERATE. IT WAS OBSERVED AFTER THE ADMINISTRATION OF PROTAMINE THAT THE PVL WAS DOING BETTER. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9738 SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention