BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA VXT

    MDR report key: 2963619 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00142
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    April 5, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    PMA / PMN Number
    K992960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION, THEREFORE, IT'S VERY DIFFICULT TO CONFIRM THE COMPLAINT. A LOT HISTORY REVIEW WAS PERFORMED AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS. THESE RESULTS INDICATE THE GRAFT HAS PERFORMED ACCORDING TO THE INDICATIONS FOR USE AND HAS MET ALL INTENDED FUNCTIONS. SEROMA FORMATION IS A KNOWN COMPLICATION OF ALL VASCULAR GRAFTS, INCLUDING BIOLOGICAL, POLYESTER, AND PTFE. LITERATURE REVIEW SUGGESTS THAT SEROMA FORMATION IS A BUILD-UP OF SERUM FLUID IN TISSUES OR ORGANS THAT OFTEN OCCURS AFTER A SURGERY.

    Description of Event or Problem · 1

    PATIENT DEVELOPED A SEROMA FORMATION FOUR MONTHS POST OPERATIVELY ((B)(6) 2011). SEROMA WAS DRAINED AND THE PATIENT CONTINUED TO TAKE A FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962 ADVANTA VXT DSY ATRIUM MEDICAL CORP. 22924 AI13110

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention ASPIRIN| WARFARIN