BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 26MM

    MDR report key: 4110294 · Received September 23, 2014

    Report

    Report Number
    2015691-2014-02211
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 2, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, DEVICE EMBOLIZATION 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 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 EMBOLIZATION (I.E. MINIMAL LEAFLET CALCIFICATION, SEVERE SEPTAL HYPERTROPHY), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. PER REPORT, TENSION ON EITHER THE SHEATH OR THE DELIVERY SYSTEM AT THE TIME OF DEPLOYMENT MAY HAVE CAUSED MOVEMENT OF THE BALLOON DURING DEPLOYMENT, RESULTING IN THE LOW PLACEMENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    AS REPORTED FROM OUR EUROPEAN AFFILIATE, THE 26MM SAPIEN XT VALVE EMBOLIZED INTO THE LEFT VENTRICLE DURING A TRANSAPICAL TAVR PROCEDURE, REQUIRING OPEN SURGICAL RETRIEVAL AND REPLACEMENT. AS REPORTED, BALLOON VALVULOPLASTY (BAV) WAS PERFORMED AND THE VALVE WAS POSITIONED IN THE NATIVE ANNULUS. BOTH THE ANGIOGRAM AND THE TEE DEMONSTRATED GOOD POSITIONING OF THE VALVE (50:50) IN RELATION TO THE ANNULUS. RAPID PACING WAS PERFORMED AT 180/MINUTE, THE PATIENT WAS STABLE AND A GOOD BLOOD PRESSURE DROP WAS NOTED. THE BALLOON WAS INFLATED AND THERE WAS A BIT OF MOVEMENT TOWARDS THE VENTRICLE. THE VALVE WAS DEPLOYED IN A TOO VENTRICULAR POSITION (70:30 AORTIC/VENTRICULAR). MILD PARAVALVULAR LEAK (PVL) WAS NOTED AND THE VALVE LOOKED UNSTABLE SO IT WAS DECIDED TO PLACE A SECOND VALVE. ON POSITIONING THE SECOND VALVE, THE ORIGINAL VALVE BECAME DISLODGED AND MOVED INTO THE VENTRICLE. THE PATIENT REMAINED STABLE AND WAS PLACED ON ECMO/BYPASS AND THEN TRANSFERRED TO THE OPERATING ROOM. AT LAST REPORT, THE PATIENT WAS DOING WELL. AS PER POST PROCEDURE DISCUSSION, THE PHYSICIANS BELIEVED THERE MAY HAVE BEEN TENSION ON EITHER THE SHEATH OR THE DELIVERY SYSTEM AT THE TIME OF DEPLOYMENT WHICH WOULD HAVE CAUSED THE MOVEMENT OF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592241 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 26MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention