BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3241597 · Received July 22, 2013

    Report

    Report Number
    2015691-2013-20653
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    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

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. HOWEVER, ADDITIONAL INVESTIGATION REVEALED THAT DUE TO AN L SHAPED AORTA, AND FAIR COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM TO THE NATIVE VALVE, THE SAPIEN VALVE WAS DEPLOYED SLIGHTLY CANTED AND A BIT VENTRICULAR. PER THE INSTRUCTIONS FOR USE, VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVE AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE EDWARDS SAPIEN RETROFLEX 3 TRANSFEMORAL DELIVERY SYSTEM TRAINING GUIDE INSTRUCTS 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 SAPIEN VALVE PERFORMANCE WILL BE IMPAIRED. IN THIS CASE, THE CAUSE OF THE CAI WAS REPORTED TO BE DUE OVERHANGING NATIVE LEAFLETS, WHICH PER INVESTIGATION, WERE DUE TO THE VALVE BEING DEPLOYED SLIGHTLY CANTED AND A BIT TOO VENTRICULAR. 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; THEREFORE NO FURTHER ACTIONS ARE REQUIRED. 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.

    Description of Event or Problem · 1

    AS REPORTED TO EDWARDS, THE PATIENT HAD 2+ CENTRAL AORTIC INSUFFICIENCY (CAI) POST DEPLOYMENT OF A SAPIEN VALVE, THE MECHANISM OF WHICH WAS FELT TO BE OVERHANGING NATIVE LEAFLETS. THE PATIENT WAS HEMODYNAMICALLY STABLE; HOWEVER, IT WAS FELT THAT OVER THE LONG RUN, THIS SIGNIFICANT AORTIC REGURGITATION COULD LEAD TO DEGENERATION OF THE SAPIEN VALVE LEAFLETS. THEREFORE A SECOND SAPIEN VALVE WAS DEPLOYED WITHIN THE FIRST VALVE, BUT SOMEWHAT HIGHER. AT THIS POINT, THERE WAS 1+ CENTRAL REGURGITATION AND TRIVIAL PARAVALVULAR REGURGITATION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND THIS WAS FELT TO BE AN ACCEPTABLE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341925 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention