BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTS FLIXENE GRAFTS W/GDS

    MDR report key: 9219651 · Received October 22, 2019

    Report

    Report Number
    3011175548-2019-01121
    Event Type
    Injury
    Date Received
    October 22, 2019
    Date of Event
    September 16, 2019
    Report Date
    October 22, 2019
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    DYF
    UDI-DI
    00650862251371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE DETAILS PROVIDED A DETERMINATION AS TO THE REASONS WHY THE GRAFT THROMBOSED IS UNKNOWN. BEING THAT THE PHYSICAL GRAFT COULD BE SEEN AT THE DISTAL INCISION AFTER 3 WEEKS MAY HAVE CONTRIBUTED TO THE THROMBOSIS FORMATION SEEN. AS MENTIONED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS FOR USE, THROMBUS FORMATION IS LISTED. THE GRAFT PRODUCT IS PROVIDED STERILE TO THE USER. THE PRODUCT IS STERILIZED USING A TRADITIONAL 3-STEP ETHYLENE OXIDE (EO) CYCLE THAT DELIVERS A 10-6 STERILITY ASSURANCE LEVEL (SAL). THIS CYCLE IS VALIDATED USING BIOLOGICAL INDICATORS (BIS) PER THE ¿OVERKILL METHOD¿ OUTLINED IN ANSI/AAMI/ISO 11135-1:2007, STERILIZATION OF HEALTH CARE PRODUCTS¿ETHYLENE OXIDE ¿ PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES. AS THE LOT NUMBER WAS NOT PROVIDED A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. CONCLUSION: ATRIUM MEDICAL CORPORATION CANNOT CONCLUDE THAT THE THROMBOSIS AND COLLAPSE OF THE GRAFT WAS DUE TO THE MANUFACTURE OR DESIGN OF THE PRODUCT.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE SUBMITTED. NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DAYS AFTER IMPLANT THE GRAFT BECAME OCCLUDED. THE GRAFT HAD TO BE EXPLANTED 3 WEEKS AFTER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016206 GRAFTS FLIXENE GRAFTS W/GDS PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER DYF ATRIUM MEDICAL CORPORATION 25137 00650862251371

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention