BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 4525441 · Received February 18, 2015

    Report

    Report Number
    2015691-2015-00370
    Event Type
    Injury
    Date Received
    February 18, 2015
    Date of Event
    January 19, 2015
    Report Date
    January 19, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS BECAUSE IT REMAINS IMPLANTED IN THE PATIENT, AS THIS WAS A VALVE-IN-VALVE (VIV) PROCEDURE. WITHOUT RETURN OF THE DEVICE, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION. ALTHOUGH THERE HAVE BEEN ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION WAS RECEIVED. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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

    Description of Event or Problem · 1

    EDWARDS RECEIVED ADDITIONAL INFORMATION INDICATING THE IMPLANT DURATION OF THE SURGICAL VALVE WAS FOURTEEN (14) YEARS, NINE (9) MONTHS.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THIS SURGICAL VALVE HAD A TRANSCATHETER VALVE IMPLANTED (VALVE-IN-VALVE) AFTER AN UNKNOWN IMPLANT DURATION. THE REASON FOR RE-OPERATION WAS DUE TO PERIVALVULAR LEAK, SECONDARY TO DEGENERATION. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115896 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R