BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE, 26MM

    MDR report key: 3942230 · Received July 17, 2014

    Report

    Report Number
    2015691-2014-01611
    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

    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 OR SEVERELY CALCIFIED AORTIC LEAFLETS, PRESERVED EJECTION FRACTION, SIGNIFICANT MITRAL ANNULAR CALCIFICATION (MAC), LOSS OF PACING CAPTURE, AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. DEPLOYMENT OF THE SAPIEN VALVE TOO AORTIC HAS THE POTENTIAL TO CONTRIBUTE TO SUBOPTIMAL COAPTATION OF THE SAPIEN VALVE LEAFLETS AND CAUSE CENTRAL AORTIC INSUFFICIENCY; IT CAN OBSTRUCT THE CORONARY OSTIA; AND LEAD TO EMBOLIZATION OF THE PROSTHESIS INTO THE ASCENDING AORTA. 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, IT WAS REPORTED THAT THE CAUSE FOR THE AORTIC MALPOSITION WAS DUE A THICKENED SEPTUM CAUSING THE FIRST VALVE TO BE DEPLOYED TOO HIGH. IN ADDITION, THE PATIENT¿S PRESERVED EJECTION FRACTION OF 70% MAY HAVE 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. 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. PER REPORT, THE VALVE BEING PLACED TOO HIGH IN THE AORTIC POSITION WAS POTENTIALLY DUE TO A THICKENED SEPTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419173 EDWARDS SAPIEN TRANSCATHETER HEART VALVE, 26MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention