BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3951323 · Received July 22, 2014

    Report

    Report Number
    2015691-2014-01656
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), VENTRICULAR MALPOSITION WITH CENTRAL REGURGITATION IS A KNOWN POTENTIAL COMPLICATION 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 VENTRICULAR MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, A NARROW, CALCIFIED SINOTUBULAR JUNCTION, MINIMALLY CALCIFIED AORTIC LEAFLETS, AND LOSS OF PACING CAPTURE. 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 VENTRICULAR MALPOSITION (I.E. SMALL, CALCIFIED STJ, MINIMAL LEAFLET CALCIFICATION), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT AT THIS TIME, THE VALVE IS NOT INDICATED FOR USE INSIDE A SURGICAL VALVE, AND THERE IS NO GUIDANCE IN THE THV TRAINING MANUAL ON USAGE OF A SAPIEN VALVE WITHIN A SURGICAL VALVE. LITERATURE SUGGESTS THAT THE THV REST 15% LOWER THAN THE PROSTHETIC VALVE. TESTING PERFORMED BY EDWARDS DOCUMENTS THE PHENOMENA OF LOW VALVE PLACEMENT OF THE SAPIEN VALVE IN A NATIVE AORTIC ANNULUS, LEADING TO LEAFLET OVERHANG, WHICH WOULD BE RELEVANT IN THE SCENARIO OF A THV IN SURGICAL HEART VALVE, AS WELL. IN THIS CASE, THE CAUSE OF THE VALVE BEING DEPLOYED LOWER THAN INTENDED IS DUE TO VALVE AND DELIVERY SYSTEM SHIFTING DURING DEPLOYMENT. HOWEVER, THE VENTRICULAR POSITION LED TO LEAFLET OVERHANG, RESULTING IN CAI. A SECOND VALVE CORRECTED THE CAI. 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 IN A NATIVE ANNULUS; THEREFORE NO FURTHER ACTIONS ARE REQUIRED. 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.

    Additional Manufacturer Narrative · 1

    EDWARDS LIFESCIENCES CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING A TRANSAORTIC THV IN SURGICAL VALVE PROCEDURE, A 23MM SAPIEN VALVE WAS POSITIONED 15% BELOW THE SURGICAL PROSTHETIC VALVE AND LANDED 20 TO 25% BELOW THE VALVE, RESULTING IN MODERATE CENTRAL AORTIC INSUFFICIENCY (CAI). A SECOND SAPIEN VALVE WAS DEPLOYED 15 TO 20% ABOVE THE FIRST SAPIEN VALVE, CORRECTING THE CAI. FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. THE CAI WAS DETERMINED TO BE FROM LEAFLET OVERHANG OF THE PROSTHETIC VALVE.

    Description of Event or Problem · 1

    DURING A TRANSAORTIC THV IN SURGICAL VALVE PROCEDURE, A 23MM SAPIEN VALVE WAS POSITIONED 15% BELOW THE EDWARDS CARPENTIER PROSTHETIC VALVE AND DEPLOYED 20 TO 25% BELOW THE VALVE, RESULTING IN MODERATE CENTRAL AORTIC INSUFFICIENCY (CAI). A SECOND SAPIEN VALVE WAS DEPLOYED 15 TO 20% ABOVE THE FIRST SAPIEN VALVE, CORRECTING THE CAI. FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. IT WAS PERCEIVED THAT VALVE AND DELIVERY SYSTEM SHIFT DURING DEPLOYMENT CAUSED THE TOO VENTRICULAR PLACEMENT. THE CAI WAS DETERMINED TO BE FROM LEAFLET OVERHANG OF THE PROSTHETIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428405 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention