BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLIXENE

    MDR report key: 2963627 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00137
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    March 20, 2009
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    PMA / PMN Number
    K060124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED FLIXENE GRAFT SEGMENTS WERE EXAMINED. THESE WERE RETURNED TO ATRIUM IN TWO SPECIMEN JARS MARKED FOR THE VENOUS AND ARTERIAL PORTIONS OF THE GRAFT. THE GRAFT SEGMENTS WERE NOT IN PRESERVATIVE, AND WERE COVERED IN BLOOD THAT WAS STILL FLUID AND NOT COAGULATED, INDICATING THAT SOME ANTI-COAGULANT OR RINSE MUST HAVE BEEN USED ON THE GRAFT SEGMENTS. TWO VENOUS SEGMENTS WERE RECEIVED, ONE APPROXIMATELY 6CM IN LENGTH, AND THE OTHER APPROXIMATELY 2CM IN LENGTH. THE ARTERIAL SEGMENT RECEIVED WAS APPROXIMATELY 5CM IN LENGTH. BOTH THE VENOUS AND ARTERIAL SEGMENTS OF THE EXPLANTED FLIXENE GRAFT DISPLAYED EVIDENCE OF CLAMP DAMAGE. THE 6CM VENOUS SEGMENT HAD CLAMP INDENTATIONS, A KINK FROM THE CLAMP, AND RESULTING PARTIAL OCCLUSION OF THE GRAFT IN THAT AREA. THE ARTERIAL PORTION OF THE FLIXENE GRAFT HAD AT LEAST TWO AREAS OBSERVED WITH CLAMP MARKS WHICH LEFT INDENTATIONS OVER THE 5CM LENGTH OF THE EXPLANT. THE INSTRUCTIONS FOR USE FOR THE FLIXENE GRAFTS CLEARLY STATE THAT "CLAMPING OF THE GRAFT SHOULD BE AVOIDED WHENEVER POSSIBLE AND LIMITED TO CLAMPS SHOD WITH SOFT MATERIAL." THE INDENTATIONS PRESENT ON THE EXPLANTED GRAFT MATERIAL INDICATE THAT NON-ATRAUMATIC CLAMPS WERE USED IN MULTIPLE LOCATIONS ON THE GRAFTS WHICH MAY HAVE CONTRIBUTED TO SEROMA FORMATION IF THE CLAMPS WERE USED AT THE TIME OF IMPLANTATION. THE QC RECORDS FOR BOTH LOTS OF GRAFT MATERIAL WERE REVIEWED AND NO ABNORMALITIES WERE SEEN. ALL RECORDS, DATA AND OBSERVATIONS INDICATE THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    A FLIXENE WAS IMPLANTED ON THE ARTERIAL END WITH THE REMAINING ADVANTA VS GRAFT AT THE VENOUS END. THE PATIENT IS HYPERTENSIVE AND DIABETIC. THE PATIENT CONTINUED TO HAVE SWELLING AND HE EXPLANTED THE FLIXENE AND THE REST OF THIS ADVANTA VS GRAFT ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1626 FLIXENE DSY ATRIUM MEDICAL CORP. 25061 PH08510

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE VS GRAFT WAS REMOVED AND WAS EVALUATED| THE VENOUS END| THE FLIXENE GRAFT WAS REMOVED AND WAS EVALUATED| FLIXENE GRAFT: #25061, LOT #PH851003 WAS IMPLANTED| ON THE ARTERIAL END WITH THE REMAINING VS GRAFT AT