BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3200615 · Received July 1, 2013

    Report

    Report Number
    2015691-2013-20503
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 7, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), DEVICE MALPOSITION REQUIRING INTERVENTION 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. PARAVALVULAR LEAK CAN OCCUR AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE WHICH CAN OCCUR DUE TO UNEVEN DISTRIBUTION OF CALCIUM. IN SOME CASES, PLACEMENT OF THE VALVE IN A TOO VENTRICULAR POSITION CAN CONTRIBUTE TO NATIVE LEAFLET OVERHANG AND CAUSE CENTRAL AORTIC INSUFFICIENCY. 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. IN THIS CASE, A COMBINATION OF PATIENT FACTORS (NARROW STJ, SEVERE NATIVE VALVE/LEAFLET CALCIFICATION) AND PROCEDURAL FACTORS (LESS THAN OPTIMAL IMAGE INTENSIFIER ANGLE) LIKELY CAUSED OR CONTRIBUTED TO THE EVENT. 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSAPICAL TAVR PROCEDURE THE 23MM SAPIEN VALVE WAS DEPLOYED IN A TOO VENTRICULAR POSITION (80:20) CAUSING AORTIC INSUFFICIENCY. A SECOND VALVE WAS IMPLANTED IN ORDER TO RESOLVE THE AORTIC INSUFFICIENCY. THE PATIENT WAS REPORTED AS DOING WELL AFTER THE PROCEDURE. PER REPORT, A 23MM SAPIEN VALVE WAS PREPARED ON THE 23MM ASCENDRA DELIVERY SYSTEM, INSERTED THROUGH THE SHEATH AND POSITIONED ACROSS THE AORTIC VALVE. RAPID PACING WAS INITIATED, RESPIRATIONS WERE HELD AND THE VALVE WAS DEPLOYED. THE VALVE MOVED VENTRICULAR DURING DEPLOYMENT AND THE BALLOON WAS COMPLETELY INFLATED BEFORE THE VALVE COULD BE REPOSITIONED. THERE WAS WIDE OPEN AORTIC INSUFFICIENCY POST DEPLOYMENT AND THE PATIENT WAS UNSTABLE. A SECOND VALVE WAS PREPARED AND DEPLOYED DURING RAPID VENTRICULAR PACING. THIS VALVE INITIALLY SETTLED RIGHT IN THE MIDDLE OF THE INITIAL PROSTHESIS BUT WAS ABLE TO BE PUSHED MORE AORTIC DURING DEPLOYMENT WITH 1/3 OF THE NEW STENT BEING PLACED ABOVE THE ORIGINAL VALVE. THE PATIENT WAS RETURNED TO ICU IN STABLE CONDITION. THE PRE-DEPLOYMENT POSITION OF THE FIRST VALVE WAS APPROXIMATELY 50:50. THE DEGREE OF NATIVE VALVE, LEAFLET AND AORTIC ROOT CALCIFICATION WAS DESCRIBED AS SEVERE. THERE WAS MILD MITRAL ANNULAR CALCIFICATION. COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND THE VALVE WAS DESCRIBED AS GOOD; THE IMAGE INTENSIFIER ANGLE WAS FAIR; THERE WAS NO LOSS OF PACING CAPTURE DURING VALVE DEPLOYMENT AND VENTILATION WAS HELD. DURING INVESTIGATION OF THIS EVENT THE FCS INDICATED THE VALVE MOVED VENTRICULAR DURING THE DEPLOYMENT DUE TO A NARROW SINOTUBULAR JUNCTION. DUE TO THE PATIENT¿S LOW BLOOD PRESSURE, THE TEAM WAS UNABLE TO ASSES IF THE REGURGITATION WAS CENTRAL OR PARAVALVULAR LEAK. THIS PATIENT¿S EJECTION FRACTION WAS 65 PERCENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298048 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention