BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3802972 · Received May 9, 2014

    Report

    Report Number
    2015691-2014-01103
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, DEVICE MALPOSITION AND PARAVALVULAR LEAK ARE KNOWN POTENTIAL ADVERSE EVENTS 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. 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, THE EXACT CAUSE OF THE TOO AORTIC PLACEMENT WAS REPORTED AS OPERATOR MOVEMENT OF THE DELIVERY SYSTEM DURING DEPLOYMENT. THE PVL WAS MOST LIKELY A RESULT OF THE TOO AORTIC PLACEMENT IN COMBINATION WITH THE SEVERE NATIVE VALVE/ LEAFLET CALCIFICATION. 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 THE TRANSAPICAL PLACEMENT OF A 26MM SAPIEN VALVE, THE VALVE LANDED TOO AORTIC, RESULTING IN MODERATE-SEVERE PVL AND THE NEED TO DEPLOY A SECOND VALVE. THE PATIENT¿S NATIVE ANNULAR DIAMETER WAS 25.5MM, WITH SEVERE NATIVE VALVE/ LEAFLET CALCIFICATION. THE FIRST VALVE WAS INITIALLY POSITIONED BETWEEN 60:40/70:30 AORTIC/VENTRICULAR, AS THIS IS WHAT WAS BEST FOR THE PATIENT. POST DEPLOYMENT THE VALVE LANDED 90:10 AORTIC, AND THERE WAS MODERATE-SEVERE PARAVALVULAR LEAK (PVL). THE VALVE WAS STABLE, BUT IT WAS DECIDED TO PLACE A SECOND VALVE. THE SECOND VALVE WAS PLACED MORE VENTRICULAR, AND LANDED 75:25 A/V WITH TRACE PVL. THE PATIENT LEFT THE PROCEDURE IN STABLE CONDITION. THERE WAS GOOD COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM AND EXCELLENT IMAGE INTENSIFIER ANGLE (IIA). IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS MOVED BY THE OPERATOR DURING DEPLOYMENT, RESULTING IN THE TOO AORTIC DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281924 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention ASCENDRA 3 DELIVERY SYSTEM