BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2853447 · Received November 30, 2012

    Report

    Report Number
    2015691-2012-18737
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED BY THE EDWARDS REPRESENTATIVE: THE SINOTUBULAR JUNCTION (STJ) DEGREE OF CALCIFICATION WAS MODERATE. THERE WAS NO VENTRICULAR SEPTAL HYPERTROPHY, OR NARROW STJ. THE IMAGE INTENSIFIER ANGLE AND THE COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM WITH THE ANNULUS WAS NOTED TO BE GOOD. DURING DEPLOYMENT THERE WAS NO LOSS OF PACING CAPTURE AND THE PATIENT'S VENTILATION WAS HELD FOR THE RECOMMENDED AMOUNT OF TIME. THE VALVE WAS DEPLOYED IN 50:50 POSITION. THE EXACT ROOT CAUSE OF THE 1ST VALVE CAI WAS NOT CLEAR; HOWEVER, THERE WAS THE POSSIBILITY THAT THE 1ST VALVE WAS OVER INFLATED / EXPANDED OR THAT A LEAFLET WAS NOT FULLY OPENING. PER THE SAPIEN VALVE INSTRUCTIONS FOR USE (IFU) AND THE EDWARDS SAPIEN/RF3 TRAINING MANUAL, AORTIC INSUFFICIENCY IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING 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. THE ROOT CAUSE OF THE REPORTED CAI POST DEPLOYMENT CANNOT BE CONFIRMED; HOWEVER, PER REPORT IT WAS POSSIBLE THAT THE 1ST VALVE WAS OVER INFLATED / EXPANDED OR THAT A LEAFLET WAS NOT FULLY OPENING. IN ADDITION, THE 2ND VALVE WAS DEPLOYED 2MM LOWER TO SEAL AROUND "SOME TOUGH CALCIUM" WITH GOOD RESULT. IN THIS CASE, IT APPEARS THAT A COMBINATION OF PATIENT (I.E. AORTIC ANNULUS CALCIFICATION) AND PROCEDURAL (I.E. POSSIBLE OVER-EXPANSION OF THE VALVE) FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. 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. 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

    PER THE TERRITORY MANAGER REPORT: AFTER THE TRANSFEMORAL DEPLOYMENT OF A SAPIEN 23MM VALVE DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT [TAVR] PROCEDURE IT WAS NOTICED THAT THERE WAS MODERATE AORTIC INSUFFICIENCY (AI) DESPITE THE VALVE BEING PLACED IN PERFECT POSITION. THE VALVE WAS RE-BALLOONED AND THE AI GOT BETTER, BUT THERE WAS STILL SOME CONCERN. THE TEAM CHOSE TO PLACE A SECOND VALVE 2MM LOWER THAN THE PREVIOUS VALVE IN AN ATTEMPT TO BETTER SEAL AROUND SOME TOUGH CALCIUM WITH A GOOD RESULT. PATIENT WAS ALIVE AND DOING WELL.

    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 9000TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention