BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE, 23MM

    MDR report key: 3961968 · Received July 28, 2014

    Report

    Report Number
    2015691-2014-01710
    Event Type
    Injury
    Date Received
    July 28, 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
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VALVE REGURGITATION INCLUDING MALPOSITION OF THE VALVE, IMPINGEMENT OF A LEAFLET DUE TO THE GUIDE WIRE, OVER INFLATION OF THE DEPLOYMENT BALLOON, POST DILATION OF THE IMPLANTED VALVE, AND SLOW RECOVERY OF ADEQUATE VENTRICULAR FLOW POST VALVE DEPLOYMENT AND RAPID PACING. ALL OF THESE FACTORS HAVE THE POTENTIAL TO CONTRIBUTE TO SUBOPTIMAL COAPTATION OF THE SAPIEN VALVE LEAFLETS AND CAUSE CENTRAL AORTIC INSUFFICIENCY. OCCASIONALLY THERE ARE CASES WHERE THE ROOT CAUSE OF THE REGURGITATION CANNOT BE DETERMINED. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER NATIVE VALVE LEAFLET ASSESSMENT, TAKING INTO CONSIDERATION THE LENGTH, BULKINESS AND DISTRIBUTION OF CALCIUM ON THE NATIVE LEAFLETS TO DETERMINE WHETHER VALVE PERFORMANCE WILL BE IMPAIRED. 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. THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE IS INDICATED FOR PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVE STENOSIS. IN THIS CASE, BORDERLINE UNDERSIZING AND A LOWER LEVEL OF CALCIFICATION (MODERATE) MAY HAVE CONTRIBUTED TO THE MILD PVL. THE ATTEMPT TO IMPROVE THE SEAL OF THE VALVE TO THE ANNULUS APPEARS TO HAVE OVERDILATED THE VALVE, CREATING THE MODERATE CAI AND NEED FOR THE 2ND VALVE. THE TRAINING MANUAL FOR THE SAPIEN THV INSTRUCTS THAT ADDITIONAL VOLUME SHOULD NOT BE ADDED FOR POST-DILATION OF THE 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 (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, A VALVE-IN-VALVE PROCEDURE WAS REQUIRED TO RESOLVE CENTRAL AORTIC INSUFFICIENCY (CAI). THE FIRST 23MM SAPIEN VALVE WAS DEPLOYED IN A 60:40 AORTIC/VENTRICULAR POSITION; MODERATE CAI WAS NOTED AND THOUGHT TO BE MOST LIKELY CAUSED BY THE WIRE. A SMALL (TRACE/MILD) PVL WAS ALSO OBSERVED AND POST DILATATION WAS PERFORMED WITH AN ADDITIONAL CC OF FLUID. AFTER POST DILATION, THE WIRE WAS PULLED BACK AND THE CAI WAS DEEMED MODERATE. A SECOND VALVE WAS DEPLOYED 50:50 IN THE NATIVE ANNULUS, SLIGHTLY MORE VENTRICULAR THAN THE FIRST VALVE (1 CELL). THE CENTRAL AI IMPROVED AND NO PVL WAS OBSERVED. THE PATIENT REMAINED STABLE. THE NATIVE AORTIC ANNULAR DIAMETER WAS MEASURED 19MM X 25MM AND 409MM² BY CT SCAN. THE NATIVE VALVE WAS MODERATELY CALCIFIED AND THE AORTIC ROOT WAS MILDLY CALCIFIED. THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, AND THE IMAGE INTENSIFIER ANGLE WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437726 EDWARDS SAPIEN TRANSCATHETER HEART VALVE, 23MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention