BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA VXT VASCULAR GRAFT > OR = 6MM

    MDR report key: 3893953 · Received June 12, 2014

    Report

    Report Number
    1219977-2014-00185
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    PMA / PMN Number
    K992960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF PERFORMING THE INVESTIGATION AND WILL SUBMIT THE FOLLOW-UP REPORT ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE DOCTOR HAD TO CUT THE GRAFT TO FIT THE RIGHT SIZE. THE GRAFT KEPT UNRAVELING, SO HE OPENED A NEW GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348693 ADVANTA VXT VASCULAR GRAFT > OR = 6MM PROSTHESIS VASCULAR GRAFT DSY ATRIUM MEDICAL CORP. 21212 10917266

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention