BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 4048304 · Received August 29, 2014

    Report

    Report Number
    2015691-2014-02035
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS, MODEL# 2800, PMA# P860057/S001. METHOD: DEVICE REMAINS IMPLANTED. ADDITIONAL MANUFACTURER NARRATIVE THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS BECAUSE IT REMAINS IMPLANTED IN THE PATIENT. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONFIRM THE CLINICAL OBSERVATION. AT THIS TIME, THE SERIAL NUMBER REMAINS UNKNOWN. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THIS AORTIC BIOPROSTHETIC VALVE IS FAILING AFTER AN IMPLANT DURATION OF TWELVE (12) YEARS DUE TO DEGENERATION. AS REPORTED, THE PATIENT WILL BE TREATED WITH A VALVE-IN-VALVE PROCEDURE USING A TRANSCATHETER HEART VALVE. THE DATE OF THE PROCEDURE IS CURRENTLY UNKNOWN. NO ADDITIONAL DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529268 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR