BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3080322 · Received April 26, 2013

    Report

    Report Number
    2015691-2013-19929
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS NOT EXPLANTED FROM THE PATIENT; HOWEVER, PER REPORT, THERE WAS NO DEVICE MALFUNCTION. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE VALVE WAS NOT PERFORMED/REQUIRED AS THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. HOWEVER, IT SHOULD BE NOTED THAT ALL VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% LEAK TESTED PRIOR TO TERMINATION. PER THE INSTRUCTIONS FOR USE (IFU) COMPLICATIONS ASSOCIATED WITH THE USE OF BIOPROSTHETIC HEART VALVES INCLUDE PARAVALVULAR LEAK AND CENTRAL LEAK. SOME PVL IS EXPECTED POST DEPLOYMENT. MANY CASES ARE MILD TO MODERATE, AND EITHER RESOLVE OVER TIME OR DO NOT CAUSE SYMPTOMS. OTHERS MAY BE MORE CLINICALLY SIGNIFICANT AND REQUIRE INTERVENTION. THE PHYSICIANS UNDERGO EXTENSIVE TRAINING BY EDWARDS LIFESCIENCES IN ORDER TO PERFORM THV PROCEDURES. TRAINING INCLUDES DEVICE PREPARATION, APPROACH, POSITIONING AND DEPLOYMENT, IMAGING, AND PROCTORED PROCEDURES. THE PHYSICIAN¿S TRAINING MANUALS INSTRUCT THE PHYSICIAN ON THE PROPER STEPS AND TECHNIQUES FOR SUCCESSFUL VALVE DEPLOYMENT. PHYSICIANS ARE TRAINED TO TAKE INTO ACCOUNT PATIENT FACTORS, SUCH AS SIGNIFICANT VALVE OVER-SIZING (= 4 MM), SEVERE SEPTAL HYPERTROPHY, MINIMAL VALVE/LEAFLET CALCIFICATION, AND PRESERVED EJECTION FRACTION (EF). TECHNICAL CONSIDERATIONS INCLUDE IMPROPER IMAGE INTENSIFIER (I/I) ANGLE, NON-COAXIAL ALIGNMENT OF THE GUIDEWIRE/ VALVE/ DELIVERY SYSTEM, IMPROPER VALVE POSITION PRE-DEPLOYMENT, BALLOON INFLATION = 3 SEC DURING DEPLOYMENT, OR LOSS OF PACING CAPTURE DURING DEPLOYMENT IN THIS PARTICULAR CASE, IT APPEARS THAT THE ROOT CAUSE OF THE AORTIC REGURGITATION (CENTRAL AND PVL) IS POSSIBLY RELATED TO A COMBINATION OF PATIENT (SEVERELY CALCIFIED NATIVE ANNULUS) AND PROCEDURAL FACTORS (AORTIC DEPLOYMENT OF VALVE). 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 PREVENTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST (CS), DURING THE TRANSFEMORAL TAVR PROCEDURE, THE FIRST VALVE WAS PREPPED AND POSITIONED IN A 50:50 POSITION; HOWEVER, DURING DEPLOYMENT THE VALVE SHIFTED AND LANDED 70:30 AORTIC WITHIN THE NATIVE ANNULUS. POST DEPLOYMENT ECHOCARDIOGRAM SHOWED MODERATE TO SEVERE CENTRAL AI AND 1-2+PVL. IN AN ATTEMPT TO RESOLVE THE PROBLEM, 1CC OF DILUTED CONTRAST WAS ADDED TO THE ATRION INFLATION DEVICE AND THE VALVE WAS POST-DILATED; HOWEVER, THE PVL WORSENED. THE DECISION WAS MADE TO DEPLOY A SECOND VALVE IN AN ATTEMPT TO RESOLVE THE LEAKS. THE SECOND VALVE WAS PLACED MORE VENTRICULAR WITH THE FIRST VALVE WITH NO CENTRAL AI OR PVL NOTED AFTER VALVE DEPLOYMENT. PER REPORT, THE PIGTAIL CATHETER (NON-EDWARDS DEVICE) WAS TRAPPED BETWEEN THE DEPLOYED VALVES AND THE DISTAL 5CM BROKE OFF AND REMAINED IN PLACE IN THE PATIENT. AT LAST REPORT, THE PATIENT WAS IN STABLE CONDITION AND DOING WELL. ADDITIONAL INFORMATION PROVIDED BY THE CS INDICATED THAT THE PATIENT DID NOT HAVE VENTRICULAR SEPTAL HYPERTROPHY, THE EJECTION FRACTION WAS 25%, THE PATIENT'S AORTIC VALVE WAS SEVERELY CALCIFIED AND THE PATIENT'S AORTIC ROOT WAS MILDLY CALCIFIED. ADDITIONALLY, THE IMAGE INTENSIFIER ANGLE AND COAXIAL ALIGNMENT WERE NOTED TO BE GOOD, VENTILATION WAS HELD DURING DEPLOYMENT AND THERE WAS NO LOSS OF PACING CAPTURE DURING DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181190 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23 59391250

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention