BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3902836 · Received June 30, 2014

    Report

    Report Number
    2015691-2014-01488
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, CENTRAL 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. IN THIS CASE, PER REPORT, THERE WAS NATIVE LEAFLET OVERHANGING THE SAPIEN VALVE LEAFLETS, WHICH CAUSED THE CENTRAL AI. 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

    DURING THE TRANSAORTIC TAVR PROCEDURE, THE 26MM SAPIEN VALVE WAS POSITIONED AND DEPLOYED 50:50 WITHIN THE NATIVE ANNULUS. THE POST DEPLOYMENT ECHOCARDIOGRAM SHOWED 3+ CENTRAL AI BETWEEN THE RIGHT AND NON CORONARY CUSP DUE TO NATIVE LEAFLET OVERHANG. THE DECISION WAS MADE TO DEPLOY A SECOND VALVE. THE SECOND 26MM SAPIEN VALVE WAS DEPLOYED IN A 60:40 AORTIC/VENTRICULAR, 2MM HIGHER THAN THE FIRST VALVE. POST DEPLOYMENT ECHOCARDIOGRAM AND ANGIOGRAM SHOWED THE REGURGITATION HAD BEEN REDUCED TO TRACE. AT THE END OF THE PROCEDURE, THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379345 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention