BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3170364 · Received June 14, 2013

    Report

    Report Number
    2015691-2013-20350
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, DEVICE MALPOSITION REQUIRING INTERVENTION 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 MALPOSITION, 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 MALPOSITION (I.E. MINIMAL LEAFLET CALCIFICATION, SEVERE SEPTAL HYPERTROPHY), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. IN THIS CASE THE CAUSE OF THE MALPOSITION CANNOT BE CONFIRMED: HOWEVER PATIENT (BULKY NATIVE VALVE / LEAFLET CALCIFICATION) AND/OR PROCEDURAL FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. AS REPORTED, THE SURGICAL TEAM BELIEVED THE VALVE ROSE AORTIC DURING VALVE DEPLOYMENT DUE TO CALCIUM. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, THAT DURING A TRANSAPICAL TAVR PROCEDURE, THE 26MM SAPIEN VALVE ROSE AND DEPLOYED IN AN 80:20 AORTIC POSITION. THERE WAS SOME CENTRAL LEAK NOTED AND THE SURGICAL TEAM ELECTED TO PLACE A SECOND 26MM VALVE. THE SECOND VALVE WAS SUCCESSFULLY IMPLANTED IN A 60:40 POSITION WITH NO CENTRAL LEAK OR PVL NOTED. IT WAS REPORTED THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS NOTED TO HAVE BULKY NATIVE VALVE / LEAFLET CALCIFICATION AND SEVERE ROOT CALCIFICATION. COAXIAL ALIGNMENT OF THE DELIVERY AND VALVE AND THE IMAGE INTENSIFIER ANGLE WERE BOTH REPORTED TO BE GOOD. ADDITIONALLY, VENTILATION WAS HELD AND THERE WAS NO LOSS OF PACING CAPTURE DURING VALVE DEPLOYMENT. IT WAS REPORTED THE SURGICAL TEAM BELIEVED THE AORTIC VALVE MOVEMENT DURING DEPLOYMENT WAS DUE TO CALCIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271128 SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention