BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2992804 · Received March 7, 2013

    Report

    Report Number
    2015691-2013-19476
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    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

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT; HOWEVER, THERE IS NO ALLEGATION OF DEVICE MALFUNCTION. PER THE INSTRUCTIONS FOR USE, DEVICE MALPOSITION REQUIRING INTERVENTION AND VALVE REGURGITATION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TAVR PROCEDURE. THERE ARE SEVERAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VENTRICULAR MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE OR DELIVERY SYSTEM, NARROW, CALCIFIED STJ, MINIMAL VALVE CALCIFICATION, AND LOSS OF PACING CAPTURE. THE PROCEDURAL DIDACTIC INSTRUCTS 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 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 THIS CASE, IT WAS REPORTED THAT THE VENTRICULAR MALPOSITION OCCURRED DUE TO CONTACT OF THE DELIVERY BALLOON WITH THE STJ, WHICH FORCED THE SYSTEM VENTRICULAR. THIS VALVE MALPOSITION AND/OR THE SEVERE NATIVE VALVE CALCIFICATION LIKELY CAUSED THE PVL ON INITIAL VALVE DEPLOYMENT. 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 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS TERRITORY MANAGER, DURING A TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE THE ASCENDRA BALLOON MOVED VENTRICULAR DURING INFLATION AGAINST THE SINOTUBULAR JUNCTION (STJ), AND THE VALVE WAS DEPLOYED TOO VENTRICULAR RESULTING IN MODERATE TO SEVERE PARAVALVULAR LEAK (PVL). A SECOND VALVE WAS IMPLANTED IN ORDER TO MITIGATE THE PVL. A SECOND VALVE WAS IMPLANTED AND THE PVL WAS REDUCED TO TRACE. THE PATIENT WAS TRANSFERRED TO THE UNIT IN STABLE CONDITION. THE ANNULAR DIAMETER MEASURE 20MM BY TEE. THE STJ DIAMETER MEASURED 17-18 MM. THE AORTIC VALVE AND LEAFLET CALCIFICATION WAS DESCRIBED AS SEVERE AND THE AORTIC ROOT CALCIFICATION WAS MILD. THE IMAGE INTENSIFIER ANGLE AND THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WERE DESCRIBED AS GOOD. DURING VALVE DEPLOYMENT VENTILATION WAS HELD AND THERE WAS NO LOSS OF PACING CAPTURE. PRE-DEPLOYMENT THE VALVE WAS POSITIONED 50:50 AND THE FINAL VALVE POSITION WAS 30:70 VENTRICULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96843 SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention