BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-PORT ANASTOMOSIS DEVICE

    MDR report key: 2893387 · Received February 24, 2006

    Report

    Report Number
    3004114958-2006-00002
    Event Type
    Injury
    Date Received
    February 24, 2006
    Date of Event
    January 23, 2006
    Report Date
    February 21, 2006
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD TRIPLE VESSEL DISEASE. SURGEON WAS PERFORMING A BEATING HEART CORONARY ARTERY BYPASS GRAFTING PROCEDURE (CABG). THE SURGEON CHOSE TO ATTACH A LEFT INTERNAL MAMMARY ARTERY TO THE LEFT ANTERIOR DESCENDING ARTERY. A SEQUENTIAL VEIN GRAFT WAS USED FROM THE AORTA AND ATTACHED TO THE OBTUSE MARGINAL ARTERY AND THE DISTAL CIRCUMFLEX ARTERY. THE C-PORT DEVICE WAS USED TO ATTACH THE DISTAL END OF A VEIN SEGMENT TO THE DISTAL CIRCUMFLEX ARTERY. THE OTHER TWO BYPASSES WERE PERFORMED USING STANDARD HAND-SEWN TECHNIQUE. AFTER CLOSURE, THE PT APPEARED TO HAVE ST ELEVATIONS ON THE LEFT LATERAL HEART. WHEN THE CHEST WAS RE-OPENED, THE C-PORT ANASTOMOSIS WAS FOUND LEAKING. A SINGLE STITCH REPAIRED THE LEAK. THE SURGEON TOOK ANOTHER PIECE OF VEIN AND PERFORMED AN ATTACHMENT FROM THE AORTA TO THE LAD TO REVASCULARIZE THE LEFT SIDE OF THE HEART. PT STABILIZED AND APPEARED FINE LEAVING THE OPERATING ROOM. SURGEON CONFIRMED THAT C-PORT LEAK WAS COINCIDENTAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-PORT ANASTOMOSIS DEVICE IMPLANTABLE CLIPS FZP CARDICA, INC. FG-000050 50927C

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention