BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3092033 · Received May 3, 2013

    Report

    Report Number
    2015691-2013-19984
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TAVR PROCEDURE THE VALVE DEPLOYED 80:20 AORTIC, WITH 2-3+ CENTRAL AORTIC REGURGITATION (CAI). THE DIASTOLIC BP WAS DECREASING, WHICH WAS INDICATIVE OF THE SEVERE CAI. IT WAS DETERMINED THAT A SECOND 26MM SAPIEN WAS APPROPRIATE FOR PLACEMENT, WHICH WAS DEPLOYED IN THE 60:40 AORTIC POSITION. THE AORTIC REGURGITATION RESOLVED TO MILD. THE PATIENT'S DIASTOLIC BP INCREASED WITHIN NORMAL LIMITS. ADDITIONAL INFORMATION REVEALED THE PATIENT HAD BULKY VALVE/LEAFLET CALCIFICATION, AND NO AORTIC ROOT CALCIFICATION. THERE WAS GOOD COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, AND GOOD IMAGE INTENSIFIER ANGLE. THERE WAS NO LOSS OF PACING CAPTURE. VENTILATION WAS NOT HELD. THE PRE-DEPLOYMENT POSITION WAS CONSIDERED 50:50.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194029 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26 3277442

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention