BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA VS

    MDR report key: 2963640 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00134
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    February 6, 2009
    Report Date
    February 11, 2009
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DYF
    PMA / PMN Number
    K992441
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADVANTA VS GRAFT SEGMENT, APPROX 7CM IN LENGTH, WAS RETURNED TO ATRIUM IN FORMALIN. THE CONTAINER WAS LABELED "GRAFT FROM LEFT ARM", BUT IT IS UNK FROM THE LABELING WHETHER THE RETURNED SEGMENT IS FROM THE VENOUS OR ARTERIAL PORTION OF THE AV GRAFT. UPON EXAMINATION OF THE SEGMENT, AT LEAST TWO CLAMP MARKS WERE VISIBLE BY THE INDENTATIONS THAT WERE LEFT IN THE GRAFT. ONE OF THE AREAS THAT WAS CLAMPED CAUSED THE GRAFT TO KINK AND PARTIALLY OCCLUDE IN THE LOCATION OF THE CLAMP MARK. THE EXPLANTED FLIXENE GRAFT SEGMENTS WERE EXAMINED NEXT. THERE 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 APPROX 6CM IN LENGTH, AND THE OTHER APPROX 2CM IN LENGTH. THE ARTERIAL SEGMENT RECEIVED WAS APPROX 5CM IN LENGTH. BOTH THE VENOUS SEGMENT WITH CLAMP INDENTATIONS, A KINK FROM THE CLAMP, AND A RESULTING PARTIAL OCCLUSION OF THE GRAFT IN THAT AREA. THE ARTERIAL PORTION OF THE FLIXENE GRAFT WITH AT LEAST TWO AREAS OBSERVED TO HAVE CLAMP MARKS LEAVING INDENTATIONS OVER THE 5CM LENGTH OF THE EXPLANT. THE INSTRUCTIONS FOR USE FOR BOTH THE ADVANTA VS AND FLIXENE PRODUCTS CLEARLY STATE THE "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. ONE OF THE AREAS THAT WAS CLAMPED CAUSED THE GRAFT TO KINK AND PARTIALLY OCCLUDE IN THE LOCATION OF THE CLAMP MARK (VS GRAFT). PARTIAL OCCLUSION OF THE GRAFT COULD CAUSE PRESSURE TO BUILD IN THE GRAFT AND CAUSE EXCESS PERMEATION THROUGH THE WALL OF THE GRAFT, RESULTING IN SEROMA FORMATION. THE QUALITY RECORDS FOR BOTH LOTS 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

    THE ADVANTA VS GRAFT WAS IMPLANTED ON (B)(6) 2008 IN THE UPPER LEFT ARM. IT WAS PARTIALLY EXPLANTED ON (B)(6) 2009 AND A FLIXENE # (B)(4), LOT # PH0851003 WAS IMPLANTED ON THE ARTERIAL END WITH THE REMAINING ADVANTA VS GRAFT AT THE VENOUS END. THE PT IS HYPERTENSIVE AND DIABETIC. THE PT CONTINUED TO HAVE SWELLING AND THE PHYSICIAN 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
    967 ADVANTA VS DYF ATRIUM MEDICAL CORP. 21611 AH27611

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VS GRAFT AT THE VENOUS END.| THE FLIXENE GRAFT WAS REMOVED WAS EVALUATED.| A FLIXENE GRAFT (#25061, LOT# PH0851003) WAS| IMPLANTED ON THE ARTERIAL END WITH THE REMAINING