BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3941014 · Received July 17, 2014

    Report

    Report Number
    2015691-2014-01608
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. THREE CELL PHONE VIDEOS OF CINE WERE SUBMITTED TO EDWARDS FOR REVIEW. THE FOLLOWING OBSERVATIONS WERE MADE: THE FIRST VIDEO DEMONSTRATES DEPLOYMENT OF THE FIRST VALVE. THERE APPEARS TO BE GOOD IMAGE INTENSIFIER ANGLE AND GOOD COAXIAL ALIGNMENT OF THE VALVE; HOWEVER, THE VALVE APPEARS TO BE POSITIONED AND DEPLOYED TOO AORTIC (~90/10). THE SECOND VIDEO CAPTURES AN AORTOGRAM POST DEPLOYMENT OF THE FIRST VALVE. THE VALVE APPEARS TO BE 90-100% ABOVE THE NATIVE AORTIC ANNULUS AND REGURGITATION IS NOTED. THE THIRD VIDEO CAPTURES DEPLOYMENT OF A SECOND VALVE (VALVE-IN-VALVE). THE SECOND VALVE APPEARS TO BE DEPLOYED 1-2 STRUTS MORE VENTRICULAR THAN THE FIRST VALVE. PER THE INSTRUCTIONS FOR USE, DEVICE MALPOSITION REQUIRING INTERVENTION AND VALVE REGURGITATION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE 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. 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. DURING THE MANUFACTURING PROCESS, ALL SAPIEN 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 INFORMATION AVAILABLE SUGGESTS THAT PATIENT FACTORS (SEVERE SEPTAL BULGE) AND PROCEDURAL FACTORS (TOO AORTIC POSITIONING OF THE VALVE PRIOR TO DEPLOYMENT) RESULTED IN THE TOO AORTIC DEPLOYMENT OF THE VALVE AND SUBSEQUENT CENTRAL REGURGITATION. PER REPORT, THE SEVERE SEPTAL BULGE MADE IT DIFFICULT FOR THE PHYSICIAN TO APPROPRIATELY POSITION THE VALVE MORE VENTRICULAR. 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 AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE TRANSAPICAL TAVR PROCEDURE, THE 23MM SAPIEN VALVE WAS POSITIONED IN A 70:30 AORTIC/VENTRICULAR POSITION, HOWEVER, DURING DEPLOYMENT THE VALVE SHIFTED AND LANDED 90:10 A/V. POST DEPLOYMENT ECHOCARDIOGRAM REVEALED MODERATE PARAVALVULAR LEAK AND MODERATE-SEVERE CENTRAL AI. THE DECISION WAS MADE TO DEPLOY A SECOND VALVE. A SECOND 23MM SAPIEN VALVE WAS DEPLOYED IN A 50:50 POSITION, 1 ½ STRUTS BELOW THE FIRST VALVE. THE PHYSICIAN STRUGGLED TO IMPLANT THE VALVE LOWER. A REPEAT ECHOCARDIOGRAM CONFIRMED THE PVL AND CENTRAL AI HAD REDUCED TO NONE. THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION. THE NATIVE ANNULUS WAS MEASURED 20-22MM BY TEE, AND 25MMX17MM, WITH AN AREA OF 350-360, BY CT. THE NATIVE AORTIC VALVE WAS MODERATELY CALCIFIED, AND THE PATIENT HAD SEVERE VENTRICULAR SEPTAL HYPERTROPHY. ADDITIONALLY, BOTH THE IMAGE INTENSIFIER ANGLE AND THE COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND VALVE WERE NOTED TO BE GOOD, VENTILATION WAS HELD DURING VALVE DEPLOYMENT AND THERE WAS NO LOSS OF PACING CAPTURE DURING VALVE DEPLOYMENT. ACCORDING TO REPORT, THE FINAL 90:10 A/V POSITION WAS DUE TO A COMBINATION OF THE 70:30 A/V POSITIONING OF THE VALVE AND THE PATIENT'S SEVERE SEPTAL BULGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419112 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention