BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLIXENE VASCULAR GRAFT

    MDR report key: 1312138 · Received February 11, 2009

    Report

    Report Number
    1219977-2009-00001
    Event Type
    Other
    Date Received
    February 11, 2009
    Date of Event
    January 13, 2009
    Report Date
    January 13, 2009
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE PRODUCTS AT THE TIME OF EXPLANT DUE TO THE INCORPORATION OF SURROUNDING TISSUE INTO THE GRAFT. IT WAS DURING THE EXPLANT PROCEDURE THAT PORTIONS OF THE OUTER GRAFT LAYER DELAMINATED FROM THE BASE STRUCTURE. TISSUE INCORPORATION INTO THE OUTER GRAFT WALL IS A SIGN THAT THE GRAFT IS HEALING WELL. IT IS EXPECTED THAT BY 5 MONTHS THIS GRAFT WOULD HAVE AT LEAST PARTIAL TISSUE INCORPORATION. THE STRENGTH OF THE TISSUE INCORPORATION INTO THE GRAFT CAN BE QUITE STRONG AND WAS THE MOST LIKELY REASON FOR DELAMINATION WHEN THE PHYSICIAN WAS TRYING TO SEPARATE GRAFT FROM THE TISSUE BED FOR REMOVAL. ALL RECORDS, DATA AND OBSERVATION INDICATE THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECS.

    Description of Event or Problem · 1

    FLIXENE GRAFT BECAME INFECTED AND UPON REMOVAL WAS FOUND TO HAVE HAD EXTENSIVE DELAMINATION. EXTENSIVE INCISIONS WERE NEEDED TO REMOVE RETAINED FRAGMENTS OF DELAMINATED GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLIXENE VASCULAR GRAFT NONE DSY ATRIUM MEDICAL CORP. 25058 AH1650515

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention