BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3232063 · Received July 17, 2013

    Report

    Report Number
    2015691-2013-20627
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, DEVICE MALPOSITION REQUIRING INTERVENTION IS A KNOWN POTENTIAL ADVERSE EVENT 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, 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. PARAVALVULAR LEAK CAN OCCUR AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE WHICH CAN OCCUR DUE TO UNEVEN DISTRIBUTION OF CALCIUM. 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, IT IS POSSIBLE THAT PATIENT (BULKY NATIVE VALVE/LEAFLET CALCIFICATION) AND PROCEDURAL FACTORS (SUBOPTIMAL PRE-DEPLOYMENT POSITION REQUIRING MANIPULATION DURING DEPLOYMENT, POOR COAXIAL ALIGNMENT) LIKELY CAUSED OR CONTRIBUTED TO THE EVENT. 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST, DURING A TRANSAPICAL TAVR PROCEDURE THE 26MM SAPIEN TRANSCATHETER HEART VALVE WAS DEPLOYED IN A "TOO" AORTIC POSITION CAUSING MODERATE TO SEVERE PARAVALVULAR LEAK. A SECOND SAPIEN VALVE WAS SUCCESSFULLY IMPLANTED RESOLVING THE PVL. PER REPORT, FOLLOWING THE BALLOON AORTIC VALVULOPLASTY WITH A 25MM Z-MED BALLOON THERE WAS SEVERE AORTIC INSUFFICIENCY. A 26MM SAPIEN VALVE WAS PREPPED ON THE ASCENDRA DELIVERY SYSTEM AND DELIVERED TRANSAPICALLY DURING UNDER RAPID VENTRICULAR PACING. INITIALLY THE VALVE¿S POST DEPLOYMENT POSITION WAS 30:70 VENTRICULAR BUT DURING BALLOON INFLATION THE VALVE MIGRATED TO 90:10 AORTIC. THERE WAS MODERATE TO SEVERE PVL THUS AN ADDITIONAL ML OF CONTRAST WAS ADDED TO THE DELIVERY SYSTEM AND THE VALVE WAS POST-DILATED. THERE WAS NO DISCERNIBLE IMPROVEMENT IN THE AORTIC INSUFFICIENCY SO THE TEAM DECIDED TO PREPARE A SECOND VALVE. THE SECOND SAPIEN VALVE WAS DEPLOYED WITH APPROXIMATELY 1 STENT CELL MORE VENTRICULAR THAN THE ORIGINAL STENTED VALVE. THE RESULT WAS ZERO PARAVALVULAR OR CENTRAL INSUFFICIENCY. THE SHEATH WAS REMOVED AND THE APEX WAS CLOSED WITHOUT DIFFICULTY. THE PATIENT WAS TRANSFERRED TO THE ICU IN A STABLE CONDITION. THE PRE-DEPLOYMENT POSITION OF THE FIRST VALVE WAS APPROXIMATELY 70:30 VENTRICULAR; THE SURGEON ADVANCED THE VALVE DURING THE DEPLOYMENT AND IT ENDED UP TOO AORTIC. THE NATIVE VALVE/LEAFLET CALCIFICATION WAS DESCRIBED AS BULKY. THE AORTIC ROOT CALCIFICATION WAS MODERATE. THE COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND THE VALVE WAS DESCRIBED AS POOR; THE IMAGE INTENSIFIER ANGLE WAS APPROPRIATE; THERE WAS NO LOSS OF PACING CAPTURE DURING VALVE DEPLOYMENT AND VENTILATION WAS HELD. THIS PATIENT¿S EJECTION FRACTION WAS 40 PERCENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330547 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention