BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

    MDR report key: 9781250 · Received March 3, 2020

    Report

    Report Number
    3004114958-2020-00001
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    January 15, 2020
    Report Date
    March 3, 2020
    Manufacturer
    AESDEX, LLC
    Product Code
    FZP
    UDI-DI
    11814900000017
    PMA / PMN Number
    K091017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, THE USER IS INSTRUCTED TO GRASP THE CONDUIT CLOSE TO THE IMPLANT WITH FORCEPS WHILE THE DEVICE IS BEING REMOVED TO AVOID PLACING TENSION ON THE ANASTOMOSIS. THE USER IS ALSO INSTRUCTED TO WET THE VENOUS CONDUIT AND THE DEVICE BY FLUSHING WITH NON-CELLULAR PHYSIOLOGIC SOLUTION IF THE VENOUS CONDUIT HAS BECOME DRIED TO THE INSIDE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING AN OFF-PUMP CORONARY ARTERY BYPASS. FOLLOWING DEPLOYMENT OF THE IMPLANT TO THE AORTA, THE SURGEON TRIED TO REMOVE THE DELIVERY DEVICE BUT FOUND IT WAS DIFFICULT TO REMOVE. THE SURGEON "STRONGLY PULLED THE DEVICE," WHICH CAUSED SEPARATION OF THE ANATOMOSIS BETWEEN THE AORTA AND THE SAPHENOUS VEIN GRAFT (SVG) WHICH HAD BEEN FORMED BY USE OF THE IMPLANT. THE SURGEON THEN COMPLETED THE BYPASS BY SUTURING THE SAME SVG AT AN ALTERNATE AORTIC LOCATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245531 CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM CLIP FZP AESDEX, LLC FG-000001 190614E 11814900000017

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention