BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 4013040 · Received August 15, 2014

    Report

    Report Number
    2015691-2014-01880
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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, AS REPORTED, THE VALVE MOVED AORTIC BEFORE DEPLOYMENT. BECAUSE OF THE PATIENT¿S HEMODYNAMIC INSTABILITY, THE POSITIONING OF THE VALVE WAS NOT CORRECTED AND THE DEPLOYMENT WAS RUSHED. PVL RESULTED AND WAS CORRECTED WITH A SECOND VALVE. 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 A TRANSFEMORAL TAVR PROCEDURE A 29MM SAPIEN XT VALVE WAS DEPLOYED TOO AORTIC RESULTING IN MODERATE PARAVALVULAR LEAK (PVL) THE BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED SUCCESSFULLY. THE SAPIEN XT VALVE CROSSED THE NATIVE ANNULUS AND WAS POSITIONED 50:50 IN THE ANNULUS. UPON CROSSING THE NATIVE ANNULUS THE PATIENT BECAME HYPOTENSIVE AND THE PHYSICIANS DECIDED TO PROCEED WITH VALVE DEPLOYMENT. BEFORE DEPLOYMENT THE VALVE MOVED AORTIC AND WAS NOT CORRECTED DURING THE RUSHED DEPLOYMENT. THE VALVE ENDED UP 90:10 AORTIC/VENTRICULAR. AFTER DEPLOYMENT, CPR WAS NEEDED TO GET THE PATIENT'S PRESSURE BACK TO BASELINE. AFTER A MINUTE OF CHEST COMPRESSIONS, THE PATIENT¿S PRESSURE RETURNED TO BASELINE. THE VALVE WAS ASSESSED ON ECHO, IT DEMONSTRATED MODERATE PVL LEAK WITH HIGH AORTIC POSITIONING. THE PHYSICIANS DECIDED TO PLACE ANOTHER VALVE TO CORRECT FOR THE LEAK AND PLACEMENT. THE SECOND VALVE WAS PLACED TWO CELL STRUTS LOWER AND DEPLOYED SUCCESSFULLY. ECHO ASSESSED THE VALVE AND DETERMINED GOOD PLACEMENT WITH MILD/MODERATE PVL LEAK POSTERIOR WHERE CALCIUM WAS NOTED ON BOTH ECHO AND CT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489404 SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX29

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention