BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM

    MDR report key: 1999468 · Received February 15, 2011

    Report

    Report Number
    3004114958-2011-00001
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    PMA / PMN Number
    K070548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN A CABG PROCEDURE THE FLEX-A DEVICE WAS DEPLOYED SUCCESSFULLY, CREATING AN ANASTOMOSIS WITH VERY GOOD FLOW. FOLLOWING SUCCESSFUL DEPLOYMENT, AS THE SURGEON WITHDREW THE DEVICE, THE DEVICE CARTRIDGE BECAME ENTANGLED ON A CLIP THAT HAD BEEN PLACED ON A BRANCH APPROXIMATELY 35MM FROM THE DISTAL END, AND PULLED IT OFF. THE DOCTOR DISCOVERED A GASH IN THE IMA. HE REPAIRED BY COMPLETELY TRANSECTING AND HANDSEWING THE VESSEL. THE ANASTOMOSIS CREATED BY FLEX-A WAS NOT TOUCHED AND REMAINS INTACT. NO SEQUELAE WAS NOTED FOLLOWING THE REPAIR. AS OF THE MOST RECENT REPORT, MADE TWO WEEKS POST OPERATIVE ON (B)(6) 2011, THE PATIENT CONDITION WAS REPORTED TO CARDICA AS, "DOING REASONABLY WELL FOLLOWING THE BYPASS SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM CLIP, IMPLANTABLE FZP CARDICA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention