BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 4842428 · Received June 12, 2015

    Report

    Report Number
    2015691-2015-01399
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 19, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER OF THE FIRST VALVE THAT WAS DEPLOYED HAS NOT BEEN CONFIRMED THEREFORE THE INFORMATION PERTAINING TO BOTH VALVES IS BEING PROVIDED: VALVE 1 MODEL 9300TFX29A, SERIAL NUMBER (B)(4), UDI REFERENCE (B)(4), MFG. DATE 12-FEB-2015, EXP. DATE 22-JAN-2017. VALVE 2 MODEL 9300TFX29A, SERIAL NUMBER (B)(4), UDI REFERENCE (B)(4), MFG. DATE 28-AUG-2014, EXP. DATE 3-AUG-2016. INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: (B)(4). ADDITIONAL INFORMATION PROVIDED BY THE HOSPITAL OPERATIVE REPORT INDICATED BALLOON AORTIC VALVULOPLASTY WAS PERFORMED DURING RAPID VENTRICULAR PACING AT A RATE OF 200 WITH SIMULTANEOUS AORTOGRAM. THE VALVE WAS DEPLOYED WITH A RAPID VENTRICULAR PACING RATE OF 220 WITH THE BALLOON AT -1.0CC VOLUME. POST DEPLOYMENT TEE SHOWED THE VALVE WAS DEPLOYED LOW, RESULTING IN MODERATE PARAVALVULAR LEAK (PVL). THE VALVE WAS POST DILATED. THE DECISION WAS MADE TO DEPLOY A SECOND VALVE IN ORDER TO ADDRESS THE MALPOSITION. A SECOND 29MM SAPIEN XT VALVE WAS PREPPED AND DEPLOYED WITHIN THE FIRST VALVE. POST DEPLOYMENT AORTOGRAM SHOWED MILD AORTIC REGURGITATION. TTE SHOWED PVL HAD REDUCED TO MILD. PER REPORT, THE PVL WAS ATTRIBUTABLE TO A LARGE, UNUSUAL CALCIUM ¿BOULDER¿ IN LVOT. THE SHEATH WAS REMOVED AND HEMOSTASIS WAS OBTAINED. PER THE INSTRUCTIONS FOR USE, VALVE MALPOSITION AND PVL ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VENTRICULAR MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, A NARROW, CALCIFIED SINOTUBULAR JUNCTION, MINIMALLY OR SEVERELY CALCIFIED NATIVE ANNULUS/LEAFLETS, LOSS OF PACING CAPTURE, AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. THE PATIENT SCREENING MANUAL AND THE PROCEDURE DIDACTIC IDENTIFY SEVERAL PROCEDURAL AND ANATOMICAL FACTORS WHICH COULD CONTRIBUTE TO PVL, INCLUDING DEVICE MALPOSITION, INACCURATE MEASUREMENT OF THE NATIVE VALVE ANNULUS, UNEVEN DISTRIBUTION OF CALCIUM ON THE NATIVE VALVE, BULKY OR SEVERE CALCIFICATION, AN ELLIPTICAL ANNULUS SHAPE AND VALVE UNDER-SIZING. 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 MALPOSITION, BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. IN THIS CASE, THE CAUSE FOR THE LOW VALVE PLACEMENT CANNOT BE DETERMINED. PER REPORT, THE PVL WAS ATTRIBUTABLE TO A LARGE, UNUSUAL CALCIUM ¿BOULDER¿ IN LVOT. 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 RECEIVED BY THE EDWARDS IMPLANT PATIENT REGISTRY, TWO 29MM SAPIEN XT VALVES WERE IMPLANTED IN THE AORTIC POSITION DURING A TRANSAORTIC TAVR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386646 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX29

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention