BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3853040 · Received June 6, 2014

    Report

    Report Number
    2015691-2014-01315
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    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

    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, PROCEDURAL FACTORS (E.G. OVERCOMPENSATION DURING VALVE DEPLOYMENT, CANTED SHEATH) LIKELY CONTRIBUTED TO THIS 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 TRANS-APICAL DEPLOYMENT OF A 26MM SAPIEN VALVE, THE OPERATOR OVERCOMPENSATED FOR SLIGHT VALVE MOVEMENT AND DEPLOYED THE VALVE IN A TOO-AORTIC POSITION (80:20 AORTIC/VENTRICULAR), RESULTING IN MODERATE PARAVALVULAR LEAK (PVL). POST DILATION, WITH AN ADDITIONAL 1CC FOR A TOTAL OF 22CC, WAS PERFORMED, CAUSING THE OUTFLOW TO FLAIR, CREATING MILD CENTRAL LEAK (CAI). THE SURGICAL TEAM DETERMINED A SECOND VALVE WAS REQUIRED. A SECOND VALVE WAS DEPLOYED WITH 1 CELL OVERLAP ON THE INFLOW TRACT. FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED IN STABLE CONDITION. THE PATIENT¿S NATIVE ANNULUS DIAMETER WAS REPORTED AS 24MM (VALVE AREA 529MM2) BY CT WITH MODERATE NATIVE VALVE CALCIFICATION AND NO ROOT CALCIFICATION. IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS COAXIAL, HOWEVER, THE SHEATH WAS CANTED. THE IMAGE INTENSIFIER ANGLE WAS REPORTED AS EXCELLENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332841 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention