BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3914457 · Received July 3, 2014

    Report

    Report Number
    2015691-2014-01535
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 9, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. WITHOUT THE RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONFIRM THE CLINICAL OBSERVATION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A (B)(4) BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    A PERICARDIAL VALVE, IMPLANTED TWELVE YEARS AND ONE MONTH, REQUIRED VALVE IN VALVE INTERVENTION. FURTHER INVESTIGATION REVEALED INTERVENTION WAS DUE TO AORTIC REGURGITATION. THERE HAVE BEEN NO REPORTS OF ADVERSE PATIENT EFFECTS AS A RESULT OF THE SECONDARY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389982 CARPENTIER-EDWARDS PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 280025MM

    Patients

    Seq Age Sex Outcome Treatment
    1 80 Required Intervention