BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2902335 · Received January 8, 2013

    Report

    Report Number
    2015691-2013-19046
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE DEVICE'S INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES INCLUDE BUT ARE NOT LIMITED TO DEVICE MALPOSITION AND PARAVALVULAR LEAK. THERE ARE SEVERAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO AORTIC MALPOSITION, INCLUDING IMPROPER SIZING OF THE VALVE, IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMAL VALVE CALCIFICATION, AND LOSS OF PACING CAPTURE. PARAVALVULAR LEAK CAN OCCUR AS A RESULT OF DEVICE MALPOSITION AND/OR A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE WHICH CAN OCCUR DUE TO UNEVEN DISTRIBUTION OF CALCIUM. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING INCLUDES 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. IN THIS CASE, PATIENT AND PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO THE EVENT. PER REPORT, THE MALPOSITION OF THE DEVICE AND SUBSEQUENT PARAVALVULAR LEAK WAS A RESULT OF THE PATIENT'S CARDIAC ANATOMY (LARGE AND OVAL SHAPED ANNULUS) AND NOT DUE TO DEVICE MALFUNCTION. IN ADDITION, IT IS POSSIBLE THAT THE PATIENT'S PRESERVED LV FUNCTION (EF 70%) COULD HAVE CONTRIBUTED TO THE AORTIC MALPOSITION. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. THE IFU AND EDWARDS THV PATIENT SCREENING 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 PREVENTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING THE TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE THE INITIAL SAPIEN VALVE WAS IMPLANTED TOO AORTIC RESULTING IN A MODERATE-SEVERE PARAVALVULAR LEAK (PVL), AND REQUIRING IMPLANTATION OF A 2ND SAPIEN VALVE. PER REPORT, THE FINAL VALVE POSITION FOR THE FIRST VALVE WAS 80:20 AORTIC. DURING THE POST-IMPLANT EVALUATION THROUGH TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) MODERATE TO SEVERE PARAVALVULAR LEAK WAS NOTED. IT WAS DETERMINED THAT A SECOND VALVE WAS NEEDED. THE SECOND VALVE WAS PLACED MORE VENTRICULAR AND POST IMPLANT TEE REVEALED THE PVL WAS NOW TRACE-MILD. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TRANSFERRED TO THE UNIT IN STABLE CONDITION. THE ROOT CAUSE OF THE TOO AORTIC POSITION OF THE VALVE WAS ATTRIBUTED TO THE PATIENT'S ANNULUS BEING LARGE AND OVAL SHAPED. ADDITIONAL INFORMATION: THIS PATIENT'S NATIVE VALVE AND LEAFLET CALCIFICATION WAS SEVERE. THE AORTIC ROOT CALCIFICATION WAS MILD AND THERE WAS MILD VENTRICULAR SEPTAL HYPERTROPHY. IMAGE INTENSIFIER ANGLE AND COAXIAL ALIGNMENT WERE REPORTED AS GOOD. THE SAPIEN VALVE POSITION PRE-DEPLOYMENT WAS 60:40 VENTRICULAR. BALLOON INFLATION WAS HELD DURING DEPLOYMENT = 3 SECONDS AND THERE WAS NO LOSS OF PACING CAPTURE DURING DEPLOYMENT. THE PATIENT'S EJECTION FRACTION WAS 70%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8986 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention