BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 4211959 · Received October 29, 2014

    Report

    Report Number
    2015691-2014-02566
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    January 15, 2013
    Report Date
    October 29, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: 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. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THIS SURGICAL VALVE HAD A TRANSCATHETER VALVE IMPLANTED (VALVE-IN-VALVE) AFTER AN IMPLANT DURATION OF APPROXIMATELY SIXTEEN (16) YEARS. THE REASON FOR RE-OPERATION WAS DUE TO STENOSIS. NO ADDITIONAL DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693586 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R