BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2862610 · Received December 10, 2012

    Report

    Report Number
    2015691-2012-18791
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CINE IMAGES AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CLIPS FOR THIS CASE WERE SUBMITTED TO EDWARDS FOR REVIEW. THE IMAGING WAS REVIEWED BY EDWARDS'S MEDICAL STAFF. FROM REVIEW OF THE LIMITED CINE AND TEE CLIPS PROVIDED, THE FOLLOWING OBSERVATIONS WERE MADE: "DEPLOYMENT" - PHONE RECORDING OF CINE RUN DURING VALVE DEPLOYMENT · UNABLE TO ASSESS VALVE CALCIFICATION AND POSITIONING AS ALL CUSPS ARE NOT VISIBLE ON IMAGES PROVIDED · FAIR COAXIAL ALIGNMENT OF DELIVERY SYSTEM WITH 50:50 POSITIONING OF VALVE ON RCC SIDE OF VALVE · NO LOSS OF PACING CAPTURE. UNABLE TO ASSESS IF VENTILATION WAS HELD DURING VALVE DEPLOYMENT. POOR IMAGE INTENSIFIER ANGLE (IIA) NOTED AND VALVE APPEARS CANTED ON FULL DEPLOYMENT OF VALVE. "ECHO POST DEPLOYMENT" - LAX VIEW OF VALVE POST DEPLOYMENT · DEMONSTRATES A CANTED VALVE WITH THE NCC EDGE OF THE VALVE TILTED TOWARDS THE VENTRICLE . "ONE (1) MONTH FOLLOW UP" (2 CLIPS) - DIFFICULT TO ASSESS AS TEE VIDEO CLIPS VERY SHORT IN DURATION AND OF POOR QUALITY. IMPRESSION: FROM THE LIMITED IMAGING CLIP PROVIDED IT IS DIFFICULT TO PROVIDE A DETAILED ASSESSMENT OF THE PROCEDURE. FROM THE INDEX PROCEDURE CINE AND TEE IMAGES OF VALVE DEPLOYMENT IT DOES APPEAR THAT THE VALVE WAS DEPLOYED CANTED WITH THE NCC EDGE OF THE VALVE MORE VENTRICULAR. POOR IIA AND LESS THAN OPTIMAL COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM / VALVE MAY HAVE CONTRIBUTED TO THE CANTED DEPLOYMENT OF THE VALVE. IMAGES FROM THE ONE MONTH FOLLOW-UP ECHO ARE NOT SUFFICIENT TO ASSESS IF THERE WAS FURTHER VENTRICULAR MOVEMENT OF THE VALVE. PER THE SAPIEN VALVE INSTRUCTIONS FOR USE (IFU) AND RF3 TRAINING GUIDE, COMPLICATIONS ASSOCIATED WITH THE USE OF THE BIOPROSTHESIS AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, INCLUDE, BUT IS NOT LIMITED TO, DEVICE MALPOSITION AND MIGRATION. 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. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVE. TRAINING INCLUDES DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. FURTHERMORE, IN THE RF3 PHYSICIAN'S TRAINING MANUAL IT IS RECOMMENDED THAT THE OPERATOR PERFORM AN AORTOGRAM, CT OR TEE PRIOR TO THV IMPLANTATION TO REVEAL BULKY CALCIFIED LEAFLETS, CALCIFIED LEFT MAIN AND LEAFLET LENGTH; DURING PREDILATION, ASSESS POSSIBLE OBSTRUCTION OF LEFT MAIN OR ANY CORONARY OSTIA FROM BULKY LEAFLET CALCIFICATION. IN THIS CASE, AS CONFIRMED IN THE CASE IMAGING PROVIDED, A COMBINATION OF PATIENT AND PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO THIS EVENT. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. THE IFU AND EDWARDS THV PATIENT SCREENING 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 PREVENTIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    PER REPORT, ON THE FOLLOW UP VISIT ONE MONTH AFTER THE SUCCESSFUL PLACEMENT OF A SAPIEN VALVE, THE SITE REPORTED THAT THE VALVE HAS MIGRATED VENTRICULAR. THE PATIENT IS NOT SYMPTOMATIC, BUT DOES HAVE MITRAL REGURGITATION (MR). THE FEAR IS THAT THE VALVE WILL CONTINUE TO MOVE VENTRICULAR AND THEN FLIP. IT IS THOUGHT THAT A VALVE IN VALVE MAY ANCHOR THIS VALVE, BUT WOULD NOT CHANGE THE MR. THE SITE IS PLANNING TO SEND THE PATIENT TO SURGERY TO REMOVE THE SAPIEN VALVE.

    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 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention