BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3090320 · Received May 2, 2013

    Report

    Report Number
    2015691-2013-19976
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 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 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, IT APPEARS THAT A TORTUOUS DESCENDING AORTA, HORIZONTAL AORTIC ROOT, AND BULKY LEAFLET CALCIFICATION LED TO POOR COAXIAL ALIGNMENT AND THE SUBSEQUENT 90:10 IMPLANTATION OF THE SAPIEN VALVE. THE AORTIC MALPOSITION AND CANTED DEPLOYMENT OF THE VALVE LIKELY CONTRIBUTED TO THE PVL. IN ADDITION, THE ELLIPTICAL SHAPE OF THE NATIVE ANNULUS (19X26MM BY CT) AND BULKY CALCIFICATION MAY HAVE ALSO CONTRIBUTED TO THE PVL. 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 MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TAVR PROCEDURE THERE WAS DIFFICULTY CROSSING THE NATIVE AORTIC ANNULUS DUE TO A LARGE 'S' CURVE IN THE DESCENDING AORTA, A HORIZONTAL AORTIC ROOT, AND BULKY CALCIFICATION ON THE NATIVE AORTIC VALVE LEAFLETS. THE VALVE KEPT GETTING CAUGHT ON CALCIUM AND MOVING, WHICH MADE VALVE POSITIONING DIFFICULT. THE SAPIEN VALVE JUMPED AORTIC DURING BALLOON INFLATION, LANDING IN A 70:30 AORTIC POSITION ON THE NCC AND A 90:10 AORTIC POSITION ON THE LCC. THERE WAS MODERATE PARAVALVULAR LEAK (PVL) AND THE PHYSICIAN WAS CONCERNED ABOUT HOW WELL THE VALVE WAS ANCHORED IN PLACE, SO A SECOND 23MM SAPIEN VALVE WAS IMPLANTED 2-3MM MORE VENTRICULAR THAN FIRST. FINAL TEE SHOWED MILD PVL AND NO CENTRAL AORTIC INSUFFICIENCY (CAI). THE PT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) IN STABLE CONDITION. THE NATIVE AORTIC ANNULUS MEASURED 21MM BY TEE AND 19X26 (AREA 361) BY CT. THE NATIVE AORTIC VALVE WAS SEVERELY CALCIFIED. THE NATIVE AORTIC ROOT WAS MODERATELY CALCIFIED. THERE WAS SEVERE MITRAL ANNULAR CALCIFICATION (MAC). THE PATIENT'S EJECTION FRACTION WAS 40%. DURING VALVE DEPLOYMENT, VENTILATION WAS HELD AND THERE WAS NO LOSS OF PACING CAPTURE. THE IMAGE INTENSIFIER ANGLE WAS DESCRIBED AS GOOD. THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WAS DESCRIBED AS POOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191292 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention