BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAIEN TRANSCATHETER HEART VALVE, 26MM

    MDR report key: 3942296 · Received July 17, 2014

    Report

    Report Number
    2015691-2014-01612
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE SEVERAL POTENTIAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO A REPORT OF A RESTRICTED OR NON-FUNCTIONING LEAFLET. BASED ON HISTORICAL REVIEW OF COMPLAINTS, THESE EVENTS ARE TYPICALLY A RESULT OF TOO VENTRICULAR DEPLOYMENT OF THE VALVE IN COMBINATION WITH NATIVE LEAFLET OVERHANG. OTHER POTENTIAL CONTRIBUTING FACTORS INCLUDE: LEAFLET IMPINGEMENT IN A HIGHLY CALCIFIED NATIVE VALVE, IMPINGEMENT OF A LEAFLET DUE TO THE GUIDE WIRE, OR SLOW RECOVERY OF ADEQUATE VENTRICULAR FLOW POST VALVE DEPLOYMENT AND RAPID PACING. THIS CAN RESULT IN A TEMPORARY DECREASE IN THE PRESSURE GRADIENT BETWEEN THE VENTRICLE AND THE AORTA, RESULTING IN AN INADEQUATE PRESSURE CHANGE TO CLOSE THE LEAFLETS. IN MANY INSTANCES THIS CAN BE OVERCOME WITH TROUBLE SHOOTING, WHICH INCLUDES BLOOD PRESSURE RECOVERY OR SUPPORT. OCCASIONALLY THERE ARE CASES WHERE THE ROOT CAUSE OF THE NON-FUNCTIONING LEAFLET CANNOT BE DETERMINED. DURING THE MANUFACTURING PROCESS, ALL EDWARDS VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR COAPTATION PRIOR TO RELEASE FOR DISTRIBUTION. THIS MAKES IT HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION WOULD CONTRIBUTE TO THE EVENT. IN THIS CASE, THE EXACT CAUSE OF THE REPORTED LEAFLET DYSFUNCTION THAT RESULTED IN CAI IS UNKNOWN. HOWEVER, THE VALVE WAS REPORTED TO BE DEPLOYED TOO VENTRICULAR AND PATIENT FACTORS (SLOW RECOVERY) MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. IN ADDITION, TROUBLESHOOTING MEASURES DID NOT CORRECT THE SITUATION. A THIRD VALVE WAS PLACED AND THE CAI WAS RESOLVED. 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

    DURING A TRANSAPICAL TAVR PROCEDURE, THE SAPIEN VALVE WAS DEPLOYED TOO HIGH IN THE AORTIC POSITION. THE VALVE WAS PERCEIVED NOT TO BE STABLE AND MODERATE PARAVALVULAR LEAK (PVL) WAS NOTED. THE DECISION WAS MADE TO PLACE A SECOND VALVE. THE SECOND VALVE WAS PLACED SUCCESSFULLY; HOWEVER, UPON REMOVING THE BALLOON IT WAS NOTED THAT THERE WAS SIGNIFICANT CENTRAL AORTIC INSUFFICIENCY (CAI). THE WIRE WAS REMOVED TO SEE IF IT WAS CAUSED BY THE WIRE BUT THE LEAK DID NOT RESOLVE. THE PATIENT DID NOT TOLERATE THE CAI AND BECAME HEMODYNAMICALLY UNSTABLE AND WAS PLACED ON TEMPORARY BYPASS. IT WAS THOUGHT THAT A LEAFLET MAY BE STUCK/NOT FUNCTIONING. TROUBLESHOOTING WAS PERFORMED BY TRYING TO MANIPULATE A PIGTAIL CATHETER IN AN ATTEMPT TO "FREE" THE LEAFLET BUT WITH NO SUCCESS. A THIRD VALVE WAS POSITIONED AND LANDED 50:50 A/V, THE CENTRAL LEAK WAS RESOLVED AND GREAT FINAL RESULT WAS NOTED. THE PATIENT¿S NATIVE AORTIC ANNULAR DIAMETER WAS 21MM X 25MM AND AREA OF 447MM2 BY CT. THE NATIVE VALVE CALCIFICATION WAS MODERATE AND THE AORTIC ROOT WAS MODERATE. PER REPORT, THERE WAS SEVERE SEPTAL HYPERTROPHY AND MILD MITRAL ANNULAR CALCIFICATION (MAC) AND THE EF WAS 72%. INITIALLY THE FIRST VALVE WAS POSITIONED 50:50 BUT IT DEPLOYED TOO AORTIC (95:5 AORTIC/VENTRICULAR). THE SECOND VALVE WAS POSITIONED 50:50 AND LANDED 30:70 A/V.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419993 EDWARDS SAIEN TRANSCATHETER HEART VALVE, 26MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention