BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER

    MDR report key: 2890346 · Received December 29, 2012

    Report

    Report Number
    2015691-2012-18978
    Event Type
    Injury
    Date Received
    December 29, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS NOTED TO HAVE MODERATE CALCIFICATION OF THE NATIVE VALVE AND LEAFLETS. PRIOR TO DEPLOYMENT OF THE FIRST EDWARDS SAPIEN VALVE, THE VALVE AND THE DELIVERY SYSTEM WERE NOTED TO HAVE GOOD COAXIAL ALIGNMENT WITH FAIR IMAGE INTENSIFIER ANGLE. VENTILATION WAS HELD DURING DEPLOYMENT OF THE VALVE WITH NO LOSS OF PACING CAPTURE. PRIOR TO DEPLOYMENT OF THE SECOND EDWARDS SAPIEN VALVE, A DIFFERENT COPLANAR VIEW WAS SELECTED WITH THE VALVE POSITIONED 60:40 AORTIC WITHIN THE ANNULUS. ACCORDING TO THE OPERATORS, THE REASON FOR THE VALVE BEING POSITIONED TOO LOW, WITHIN THE NATIVE ANNULUS, WAS POSSIBLY DUE TO AN INADEQUATE CO-PLANER VIEW OF THE IMAGE INTENSIFIER. IN ADDITION, THE OPERATORS INDICATED THAT THE PATIENT'S AORTIC ANNULUS, MEASURING 24.5-25MM, MAY HAVE BEEN TOO LARGE FOR THE 26MM VALVE. THE ANNULUS WAS ALSO FOUND TO BE OVERLY OVAL IN SHAPE AND THE TEE MEASUREMENT OF THE ANNULUS WAS THE SHORT AXIS MEASUREMENT. PER THE EDWARDS SAPIEN VALVE INSTRUCTIONS FOR USE (IFU) AND THE THV TRAINING GUIDE, VALVE EMBOLIZATION IS A KNOWN POTENTIAL COMPLICATIONS 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 AND/OR EMBOLIZATION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, UNDER-SIZING OF VALVE, POOR IMAGE INTENSIFIER ANGLE (IIA), POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMAL VALVE CALCIFICATION, AND LOSS OF PACING CAPTURE. TECHNICAL CONSIDERATIONS INCLUDE IMPROPER IMAGE INTENSIFIER (I/I) ANGLE (UNABLE TO VIEW ALL 3 CUSPS IN A PLANE), NON-COAXIAL ALIGNMENT OF THE GUIDEWIRE/ VALVE/ DELIVERY SYSTEM, IMPROPER VALVE POSITION PRE-DEPLOYMENT, BALLOON INFLATION = 3 SEC DURING DEPLOYMENT, OR LOSS OF PACING CAPTURE DURING DEPLOYMENT. PROCEDURAL TRAINING INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING ALSO 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 ADDITION THE PHYSICIANS ARE TRAINED TO VERIFY POST DEPLOYMENT POSITION OF THE PROSTHETIC VALVE TO ASSESS FOR BALLOON DILATATION REQUIREMENT. THE TRAINING MANUALS STATE THAT SOME PVL IS EXPECTED POST DEPLOYMENT AND TO CONSIDER REPEAT BALLOON EXPANSION IF THE PVL IS SEVERE. IN THIS CASE, AS STATED, IT IS POSSIBLE THAT, IN ADDITION TO PROCEDURAL FACTORS (SUB-OPTIMAL COPLANAR ANGLE FOR VALVE POSITIONING), PATIENT FACTORS (MODERATELY CALCIFIED, LARGER OVAL SHAPED ANNULUS) COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS NO REPORT OF DEVICE MALFUNCTION THAT RESULTED IN THIS EVENT. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS 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 VIA THE EDWARDS CLINICAL SPECIALIST, DURING A TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE EDWARDS SAPIEN VALVE EMBOLIZED INTO VENTRICLE IMMEDIATELY AFTER DEPLOYMENT. A SECOND EDWARDS SAPIEN VALVE WAS PLACED IN A SLIGHTLY HIGHER POSITION (60:40 AORTIC) WITHIN THE ANNULUS. THE SECOND VALVE EMBOLIZED INTO VENTRICLE 15 MINUTES POST DEPLOYMENT. THE PATIENT WAS NOTED TO BE STABLE AFTER THE PROCEDURE. ACCORDING TO THE CASE SUMMARY, THE FIRST EDWARDS SAPIEN VALVE WAS PREPARED AND POSITIONED APPROXIMATELY IN A 60:40 VENTRICULAR POSITION. DURING SLOW, CONTROLLED DEPLOYMENT, UNDER RAPID PACING, THE VALVE SUDDENLY JUMPED VENTRICULAR AND CAME TO REST IN THE PATIENT'S LEFT VENTRICLE (LV). A SECOND 26MM SAPIEN VALVE WAS PREPPED AND POSITIONED AFTER A DIFFERENT CO-PLANER VIEW WAS SELECTED. THE SAPIEN WAS TRACKED THROUGH THE FIRST EMBOLIZED VALVE WHICH WAS STILL IN THE VENTRICLE, AND POSITIONED IN THE NATIVE ANNULUS AT 60:40 AORTIC. THE VALVE WAS DEPLOYED UNDER RAPID PACING AND REMAINED IN ITS ORIGINAL POSITION. WHILE PREPPING THE PATIENT TO BE PLACED ON CARDIOPULMONARY BYPASS (CPB), TO ALLOW THE RETRIEVAL OF THE FIRST EMBOLIZED VALVE, THE SECOND VALVE EMBOLIZED INTO THE LEFT VENTRICLE AS WELL. THIS OCCURRED APPROX. 15-20 MINUTES POST DEPLOYMENT OF THE VALVE. (REFERENCE RELATED FDA REPORT #2015691-2012-18977 - THIS REPORT WAS SUBMITTED FOR THE ADVERSE EVENT RELATED TO THE EMBOLIZATION OF THE FIRST EDWARDS SAPIEN VALVE.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SAPIEN TRANSCATHETER AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention