BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA VXT

    MDR report key: 2963544 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00149
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    April 3, 2009
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    PMA / PMN Number
    K992960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GRAFT WAS RETURNED DRY IN NO FIXATIVE. THE GRAFT WAS IN TWO PIECES, CUT ALMOST IN THE CENTER, AND HAD BLOOD ON THE OUTSIDE SURFACE. IN THE LOCATION WHERE THE GRAFT WAS CUT IN HALF, THE EPTFE RADIAL REINFORCEMENT WRAP MATERIAL WAS PEELED FROM BOTH GRAFT SEGMENTS. THE CUT ON THE GRAFT SEGMENTS WHERE THE WRAP IS PEELED DOES NOT APPEAR TO BE A CLEAN CUT, BUT RATHER A JAGGED EDGED THAT MAY HAVE RESULTED FROM THE INSTRUMENT USED TO CUT THE GRAFT OR THE TECHNIQUE USED TO CUT THE GRAFT. AN IMPROPER CUT MAY HAVE LIFTED THE WRAP MATERIAL FROM THE BASE GRAFT. MANUALLY PULLING ON THE LIFTED WRAP MATERIAL FROM THE BASE GRAFT. MANUALLY PULLING ON THE LIFTED WRAP MATERIAL WILL CAUSE IT TO UNRAVEL FROM THE BASE GRAFT, AS IT IS BEING PULLED IN A DIRECTION OPPOSITE THE WAY IT WAS ORIGINALLY WRAPPED AND THERMALLY ADHERED TO THE BASE GRAFT. FROM A CLINICAL PERSPECTIVE, THE BASE GRAFT ALONE MAINTAINS ENOUGH MECHANICAL STRENGTH TO FUNCTION AS A VASCULAR GRAFT AND ATRIUM SELLS A NON-REINFORCED VERSION OF EPTFE VASCULAR GRAFTS CALLED ADVANTA VS THE QC RECORDS FOR THIS LOT OF GRAFT MATERIAL WERE REVIEWED AND NO ABNORMALITIES WERE SEEN. ALL RECORDS, DATA AND OBSERVATIONS INDICATE THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECS. WITH THE INFORMATION GIVEN WE ARE UNABLE TO DETERMINE A DEFINITIVE CAUSE OF THE WRAP LIFTING.

    Description of Event or Problem · 1

    PHYSICIAN TRIED TO STRAIGHTEN THE GRAFT AND IT RIPPED WHERE HE HAD FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588 ADVANTA VXT DSY ATRIUM MEDICAL CORP. 21115 AE17405

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED ANOTHER GRAFT