BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3910860 · Received July 2, 2014

    Report

    Report Number
    2015691-2014-01508
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE - THE REPORTED DEVICE WILL NOT BE RETURNED TO MANUFACTURER AS IT REMAINS IMPLANTED. WITHOUT RECEIPT OF THE DEVICE THE REPORTED CLINICAL OBSERVATION CANNOT BE CONFIRMED. EDWARDS WILL CONTINUE TO MONITOR ALL EVENTS. ADDITIONAL INFORMATION WILL BE REPORTED IF RECEIVED.

    Description of Event or Problem · 1

    UPDATE RECEIVED INDICATES PATIENT UNDERWENT IMPLANT OF AN EDWARDS TRANSCATHETER AORTIC BIOPROSTHETIC VALVE WITHIN THE EXISTING VALVE. THERE ARE NO ADVERSE EVENT REPORTED FOLLOWING IMPLANT.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION OF A BIOPROSTHETIC VALVE THAT NOW EXHIBITS HIGH GRADIENTS 11 YEARS AFTER IMPLANT. PATIENT IS EXPECTED TO UNDERGO IMPLANT OF AN EDWARDS TRANSCATHETER AORTIC BIOPROSTHETIC VALVE WITHIN THE EXISTING VALVE. NO OTHER DETAILS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388260 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R