BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PHYSIO ANNULOPLASTY RING

    MDR report key: 3914504 · Received July 3, 2014

    Report

    Report Number
    2015691-2014-01536
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    April 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    AN ANNULOPLASTY RING, IMPLANTED IN THE MITRAL POSITION FOUR YEARS AND SIX MONTHS, WAS EXPLANTED DUE TO SEVERE PANNUS INGROWTH AND STENOSIS. THE EXPLANTED DEVICE WAS REPLACED WITH A PERICARDIAL VALVE. IT WAS FURTHER REPORTED THAT TESTS CONFIRMED ANNULAR PANNUS WITH FIBROSIS AND PATCHY CHRONIC INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390298 CARPENTIER-EDWARDS® PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450M28

    Patients

    Seq Age Sex Outcome Treatment
    1 30 Required Intervention