BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 6139127 · Received December 1, 2016

    Report

    Report Number
    2015691-2016-03534
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 9, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10.
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND EDWARDS INTUITY ELITE AORTIC VALVE, MODEL # 8300AB, PMA# P150036. THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. BASED ON THE INFORMATION RECEIVED THE CAUSE OF THE EVENT CANNOT BE DETERMINED. TRENDS WILL CONTINUE TO BE MONITORED THROUGH THE USE OF EDWARDS QUALITY SYSTEMS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED NOTIFICATION THAT A PATIENT WITH A 21MM AORTIC VALVE IMPLANTED IN THE AORTIC POSITION REQUIRED TRANSCATHETER VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF FOUR YEARS, THREE MONTHS, DUE TO HIGH GRADIENT OF 65MMHG. A 20MM TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED WITHIN THE DISABLED 21MM VALVE BY TRANSFEMORAL APPROACH. THE OUTCOME WAS NOTED AS TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789829 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R