BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2884195 · Received December 21, 2012

    Report

    Report Number
    2015691-2012-18931
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LIMITED CINE IMAGES WERE SUBMITTED FOR REVIEW, NO ECHO PROVIDED OBSERVATIONS/IMPRESSION: OBSERVATIONS: MILD AORTIC VALVE CALCIFICATION, MODERATE AORTIC ROOT CALCIFICATION, NO PORCELAIN AORTA, NO MAC; STABLE BAV X1 DEMONSTRATED ON CINE; POOR COAXIAL ALIGNMENT WITH SIGNIFICANT LATERAL BIAS OF THE DELIVERY SYSTEM AND VALVE. THERE ARE NO CINE IMAGES OF VALVE DEPLOYMENT. THERE IS A SHORT CINE RUN WHERE BALLOON INFLATION APPEARS TO START AND VALVE POSITIONING APPEARS TO BE 70:30 VENTRICULAR WITH STRAIGHT AP IIA (LAO 0 / CRAN 0). GOOD IMAGE INTENSIFIER ANGLE (IIA) BASED ON LAO 0 / CRAN 0 POST DEPLOYMENT. NO POST DEPLOYMENT AORTOGRAM AND UNABLE TO ASSESS FINAL POSITIONING BASED ON AVAILABLE CINE IMAGES. IMPRESSIONS: THERE WERE NO CINE IMAGES OF VALVE DEPLOYMENT. ADDITIONALLY THERE WERE NO POST DEPLOYMENT AORTOGRAM SHOTS TO CONFIRM FINAL VALVE DEPLOYMENT POSITION HOWEVER IT WAS NOTED THAT THERE WAS SIGNIFICANT LATERAL BIAS OF THE DELIVERY SYSTEM / VALVE WITH TOO VENTRICULAR POSITIONING (70:30) ON INITIAL BALLOON INFLATION. ADDITIONALLY, IT WAS NOTED THAT THERE WAS MILD AORTIC VALVE CALCIFICATION. THESE FINDING COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT THOUGH CANNOT BE CONFIRMED DUE TO THE LIMITED IMAGING AVAILABLE FOR REVIEW ACCORDING TO THE IFUS, COMPLICATIONS ASSOCIATED WITH THE USE OF BIOPROSTHETIC HEART VALVES INCLUDE DEVICE MIGRATION DUE TO IMPROPER SIZING, AND DEPLOYMENT OR IMPROPER IMPLANTATION LOCATION. THE IFU AND TRAINING MANUALS DESCRIBE THE STEPS TO FOLLOW AND CONSIDER WHEN CROSSING THE NATIVE VALVE, INCLUDING THE CORRECT ORIENTATION OF THE SYSTEM. IN ADDITION, THE TRAINING MANUALS INSTRUCT THE OPERATOR ON WHAT TO CHECK FOR IF PROBLEMS CROSSING THE VALVE ARE ENCOUNTERED, INCLUDING EXCESSIVE CALCIFICATION. THE PHYSICIAN'S UNDERGO EXTENSIVE TRAINING BY EDWARDS LIFESCIENCES IN ORDER TO PERFORM THV PROCEDURES. TRAINING INCLUDES DEVICE PREPARATION, APPROACH, POSITIONING AND DEPLOYMENT, IMAGING, TRAINING MANUALS AND PROCTORED PROCEDURES. THE PHYSICIAN'S TRAINING MANUALS INSTRUCT THE PHYSICIAN ON THE PROPER STEPS AND TECHNIQUES FOR SUCCESSFUL VALVE DEPLOYMENT. IN THIS CASE, PATIENT (MILD NATIVE AORTIC VALVE CALCIFICATION) AND PROCEDURAL FACTORS (LATERAL BIAS OF THE DELIVERY SYSTEM AND TOO VENTRICULAR DEPLOYMENT) LIKELY CAUSED OR CONTRIBUTED TO THE VALVE MIGRATING TO A CANTED POSITION POST PROCEDURE. THERE IS NO DOCUMENTATION OF DEVICE MALFUNCTION. 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.

    Additional Manufacturer Narrative · 1

    IMAGING WAS REVIEWED BY AN EDWARDS PHYSICIAN PROCTOR WHO CONFIRMED THE CAUSE OF THE EVENT DUE TO THE VALVE POSITION TOO LOW AFTER DEPLOYMENT. THERE IS NO ALLEGATION OF DEVICE MALFUNCTION. 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.

    Additional Manufacturer Narrative · 1

    THIS PATIENT WAS NOTED TO HAVE SEVERE NATIVE AORTIC VALVE AND LEAFLET CALCIFICATION WITH MILD AORTIC ROOT CALCIFICATION. PRIOR TO DEPLOYMENT, THE EDWARDS SAPIEN VALVE WAS POSITIONED 50:50 WITHIN THE ANNULUS. COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND THE VALVE WERE NOTED TO BE GOOD ALONG WITH GOOD IMAGE INTENSIFIER ANGLE PRIOR TO VALVE DEPLOYMENT. DURING DEPLOYMENT VENTILATION WAS HELD AND THERE WAS NO LOSS OF PACING CAPTURE. POST DEPLOYMENT THE VALVE WAS NOTED TO BE IN A 60:40 VENTRICULAR POSITION. ACCORDING TO THE IFUS, COMPLICATIONS ASSOCIATED WITH THE USE OF BIOPROSTHETIC HEART VALVES INCLUDE DEVICE MIGRATION DUE TO IMPROPER SIZING, AND DEPLOYMENT OR IMPROPER IMPLANTATION LOCATION. THE IFU AND TRAINING MANUALS DESCRIBE THE STEPS TO FOLLOW/CONSIDER WHEN CROSSING THE NATIVE VALVE, INCLUDING THE CORRECT ORIENTATION OF THE SYSTEM. IN ADDITION, THE TRAINING MANUALS INSTRUCT THE OPERATOR ON WHAT TO CHECK FOR IF PROBLEMS CROSSING THE VALVE ARE ENCOUNTERED, INCLUDING EXCESSIVE CALCIFICATION. THE PHYSICIAN'S UNDERGO EXTENSIVE TRAINING BY EDWARDS LIFESCIENCES IN ORDER TO PERFORM THV PROCEDURES. TRAINING INCLUDES DEVICE PREPARATION, APPROACH, POSITIONING AND DEPLOYMENT, IMAGING, TRAINING MANUALS AND PROCTORED PROCEDURES. THE PHYSICIAN¿S TRAINING MANUALS INSTRUCT THE PHYSICIAN ON THE PROPER STEPS AND TECHNIQUES FOR SUCCESSFUL VALVE DEPLOYMENT. THERE WAS NO REPORT OF DEVICE MALFUNCTION THAT RESULTED IN THIS EVENT. IN THIS CASE, THE PROBABLE CAUSE OF THE VALVE CANTING WAS LOW PLACEMENT OF THE VALVE DURING THE INDEX PROCEDURE. HOWEVER, THIS HAS NOT BEEN CONFIRMED AND IMAGING REVIEW FOR THE EXACT CAUSE OF THE REPORTED EVENT IS PENDING REVIEW. INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    AS REPORTED VIA THE EDWARDS CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, 7 HOURS POST SUCCESSFUL DEPLOYMENT OF THE EDWARDS SAPIEN VALVE, THE PATIENT WENT TO SURGERY FOR AN OPEN AORTIC VALVE REPLACEMENT (AVR) PROCEDURE DUE TO HEMODYNAMIC INSTABILITY. ECHO IMAGING CONFIRMED THAT THE SAPIEN VALVE WAS NOT DEPLOYED IN THE CORRECT POSITION. DURING SURGERY IT WAS DISCOVERED THAT VALVE HAD CANTED APPROXIMATELY 90 DEGREES. THERE WAS NO PVL OR CENTRAL LEAK POST DEPLOYMENT OF THE VALVE. THE AVR SURGERY WAS PERFORMED SUCCESSFULLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention