BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

    MDR report key: 2478970 · Received March 2, 2012

    Report

    Report Number
    3004114958-2012-00001
    Event Type
    Injury
    Date Received
    March 2, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 6, 2012
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    PMA / PMN Number
    K081225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PAS-PORT DEVICE WAS USED FOR PROXIMAL ANASTOMOSIS OF SVG IN OPCAB SURGERY ON (B)(6), 2012. THE DEVICE FIRING AND DEPLOYMENT WAS SUCCESSFUL. HOWEVER, 30 TO 40 MINUTES AFTER DEPLOYMENT, BLEEDING WAS OBSERVED AROUND THE PAS-PORT IMPLANT SITE. DISSECTION BY BLOOD PRESSURE WAS SUSPECTED, SO THE AORTA WAS CROSS CLAMPED AND A PROXIMAL-TO-DISTAL DISSECTION OF THE AORTA CONFIRMED. THE PROCEDURE PLAN WAS CHANGED TO ASCENDING AORTA REPLACEMENT, AND THAT PROCEDURE WAS COMPLETED. NO PATIENT CONDITION UPDATE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM CARDIOVASCULAR SURGICAL INSTRUMENT FZP CARDICA, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention