BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLIXENE VASCULAR GRAFT

    MDR report key: 4691844 · Received April 14, 2015

    Report

    Report Number
    1219977-2015-00119
    Event Type
    Injury
    Date Received
    April 14, 2015
    Report Date
    March 31, 2015
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE INVESTIGATION WAS NOT ABLE TO BE PERFORMED AS NO PRODUCT CODE, LOT NUMBER, OR SAMPLE WAS PROVIDED. PER THE STUDY, IT SUGGESTS THAT CANNULATION OF THE FLIXENE GRAFT WITHIN 1 WEEK AFTER IMPLANTATION IS SAFE AND EFFECTIVE. EARLY CANNULATION AVOIDS OR SHORTENS THE NEED FOR A TEMPORARY CATHETER. ONE-YEAR PATENCY RATES APPEARED TO BE COMPARABLE TO THOSE ACHIEVED WITH CONVENTIONAL GRAFTS. RELATED MDR'S: 1219977-2015-00118, 1219977-2015-00120, 1219977-2015-00121, 1219977-2015-00122, 1219977-2015-00123, 1219977-2015-00124.

    Description of Event or Problem · 1

    RECEIVED AN ARTICLE TITLED "USE OF THE FLIXENE VASCULAR ACCESS GRAFT AS AN EARLY CANNULATION SOLUTION" PUBLISHED IN THE JOURNAL OF VASCULAR SURGERY IN 2015. THE STUDY CONSISTED OF EVALUATING EARLY CANNULATION OF A PROSTHETIC GRAFT INVOLVING 44 PTS FROM 2011 THROUGH 2013 AND REPORTING THE MIDTERM PATENCY AND COMPLICATION RATES. PER THE STUDY, ONE PT HAD THE GRAFT REMOVAL AT 2 MONTHS DUE TO SUSPICION OF INFECTION. CULTURES WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247436 FLIXENE VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention