BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3120908 · Received May 20, 2013

    Report

    Report Number
    2015691-2013-20136
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. 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, PER THE IMPLANTING PHYSICIAN, THE NATIVE LEAFLETS WERE LONGER THAN NORMAL AND CONSEQUENTLY OVERHUNG THE SAPIEN VALVE LEAFLETS, CAUSING THE CAI. 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 AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, FOLLOWING THE IMPLANTATION OF A 26MM SAPIEN VALVE VIA A TRANSAPICAL APPROACH, THE NATIVE VALVE LEAFLETS WERE NOTED TO BE OVERHANGING THE SAPIEN VALVE, RESULTING IN CONSIDERABLE CENTRAL AORTIC INSUFFICIENCY (CAI). IN ORDER TO PIN BACK THE NATIVE LEAFLETS, A SECOND SAPIEN VALVE WAS PLACED SLIGHTLY MORE AORTIC INSIDE THE FIRST VALVE. THE PATIENT SOON AFTER BECAME STABLE AND WAS CLOSED IN THE NORMAL FASHION. THE NATIVE AORTIC ANNULAR DIAMETER WAS 24.5MM BY TEE AND 24MMX28MM (AREA 556) BY CT. THERE WAS BULKY CALCIFICATION ON THE NATIVE AORTIC VALVE. PER THE IMPLANTING PHYSICIAN, THE NATIVE VALVE LEAFLETS WERE LONGER THAN NORMAL. THE FIRST SAPIEN VALVE WAS PLACED 50:50 ACROSS THE NATIVE AORTIC ANNULUS, BUT THE NATIVE VALVE LEAFLETS COULD STILL BE SEEN OVERHANGING THE SAPIEN LEAFLETS, WHICH CAUSED THE CAI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221828 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A 3113365

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention