BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

    MDR report key: 8786235 · Received July 12, 2019

    Report

    Report Number
    3004114958-2019-00002
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    June 14, 2019
    Report Date
    July 12, 2019
    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

    THE DEVICE WAS RETURNED FOR INVESTIGATION, BUT NEITHER THE CLIP NOR ANY ACCESSORIES WERE RETURNED WITH THE DEVICE. BASED ON THE VISUAL AND FUNCTIONAL ASSESSMENTS OF THE RETURNED DEVICE, THERE WERE NO ISSUES FOUND WITH THE DEVICE AND THE DEVICE FUNCTIONED AS INTENDED. THEREFORE A ROOT CAUSE OR CAUSES OF THE REPORTED EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING AN ON-PUMP BEATING HEART CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE. THE SURGEON ELECTED TO USE THE PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM TO ANASTOMOSE THE PROXIMAL PORTION OF THE SAPHENOUS VEIN GRAFT (SVG) TO THE AORTA. AS REPORTED, THE CONDITION OF THE AORTA WAS "NOT GOOD". AFTER DEPLOYING THE PAS-PORT CLIP, THE SURGEON LIFTED THE DEPLOYMENT PORTION OF THE DEVICE WHILE HOLDING THE CLIP/SVG WITH FORCEPS. THE CLIP DISLODGED FROM THE ANASTOMOSIS SITE, WHICH REQUIRED THAT THE SURGEON REPAIR THE AORTIC ANASTOMOSIS SITE. THE SURGEON COMPLETED THE CABG PROCEDURE. FOLLOWING SURGERY, IT WAS REPORTED THAT THE PATIENT WAS INITIALLY UNCONSCIOUS. THE CAUSE WAS NOT REPORTED BUT A CEREBRAL INFARCTION WAS RULED OUT. THE PATIENT SUBSEQUENTLY REGAINED CONSCIOUSNESS AND IMPROVED SUCH THAT THE PATIENT IS TOLERATING FOOD CONSUMPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578220 CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM CLIP FZP AESDEX, LLC FG-000001 180301B 11814900000017

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other| R