BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3200093 · Received July 1, 2013

    Report

    Report Number
    2015691-2013-20500
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY REMAIN IMPLANTED IN THE PATIENT. PER THE INSTRUCTIONS FOR USE, DEVICE MALPOSITION AND DEVICE EMBOLIZATION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO AORTIC MALPOSITION/EMBOLIZATION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMALLY CALCIFIED AORTIC LEAFLETS, PRESERVED EJECTION FRACTION, AND LOSS OF PACING CAPTURE. THE THV TRAINING MANUALS INSTRUCT 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 PATIENT SCREENING, 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. OPERATORS ARE ALSO INSTRUCTED TO USE FLUOROSCOPY AS THE PRIMARY METHOD OF VISUALIZATION FOR POSITIONING AND DEPLOYMENT. IN PATIENTS WITH HIGH-RISK ANATOMICAL FEATURES FOR AORTIC MALPOSITION (I.E. MINIMAL LEAFLET CALCIFICATION, SEVERE SEPTAL HYPERTROPHY), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT IN THIS CASE, PATIENT (SEVERELY CALCIFIED NATIVE ANNULUS) AND PROCEDURAL FACTORS (LOSS OF PACING CAPTURE, STORED TENSION IN THE DELIVERY SYSTEM) LIKELY CAUSED OR CONTRIBUTED TO THE EVENTS. PER REPORT, LOSS OF PACING CAPTURE IN CONJUNCTION WITH A PREMATURE VENTRICULAR CONTRACTION CAUSED THE FIRST SAPIEN VALVE TO EMBOLIZE INTO THE ASCENDING AORTA. ADDITIONALLY, THE PHYSICIAN REPORTED THAT THE AORTIC MOVEMENT OF THE SECOND SAPIEN VALVE WAS CAUSED BY STORED TENSION IN THE DELIVERY SYSTEM. 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TAVR PROCEDURE, DURING VALVE DEPLOYMENT PACING CAPTURE WAS LOST IN CONJUNCTION WITH A PREMATURE VENTRICULAR CONTRACTION (PVC), WHICH CAUSED THE 26MM SAPIEN VALVE TO EMBOLIZE INTO THE ASCENDING AORTA. THE EMBOLIZED VALVE WAS CAPTURED WITH THE DELIVERY SYSTEM AND BROUGHT AROUND THE AORTIC ARCH AND DEPLOYED IN THE DESCENDING AORTA BELOW THE RENAL ARTERIES. A SECOND 26MM SAPIEN VALVE WAS THEN POSITION ACROSS THE NATIVE AORTIC ANNULUS, BUT UPON DEPLOYMENT THE VALVE MOVED AORTIC AND MISSED THE AORTIC ANNULUS ENTIRELY, LANDING IN A 100% AORTIC POSITION. THE PHYSICIAN REPORTED THAT THE AORTIC MOVEMENT WAS CAUSED BY STORED TENSION IN THE DELIVERY SYSTEM. A THIRD 26MM SAPIEN VALVE WAS THEN SUCCESSFULLY DEPLOYED 50:50 ACROSS THE NATIVE AORTIC ANNULUS, RESULTING IN NO CENTRAL AORTIC INSUFFICIENCY (CAI) OR PARAVALVULAR LEAK (PVL). THE PATIENT WAS NOTED TO BE IN STABLE CONDITION FOLLOWING THE PROCEDURE. THE NATIVE AORTIC ANNULAR DIAMETER WAS 24.7MM BY TEE. THE NATIVE AORTIC VALVE WAS SEVERELY CALCIFIED. THERE WAS NO MITRAL ANNULAR CALCIFICATION (MAC) OR VENTRICULAR SEPTAL HYPERTROPHY. THE PATIENT'S EJECTION FRACTION (EF) WAS 40%. VENTILATION WAS HELD DURING VALVE DEPLOYMENT. THE IMAGE INTENSIFIER ANGLE AND THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WERE BOTH DESCRIBED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299242 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A 3487432

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention