BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

    MDR report key: 1622484 · Received March 1, 2010

    Report

    Report Number
    3004114958-2010-00001
    Event Type
    Injury
    Date Received
    March 1, 2010
    Date of Event
    January 21, 2010
    Report Date
    January 21, 2010
    Manufacturer
    CARDICA, INC.
    Product Code
    NCA
    PMA / PMN Number
    081225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAS-PORT DEVICE WAS UNLIKELY TO BE THE CAUSE OF THE EVENT. THE OBSERVED PSEUDOANEURYSM WAS LIKELY TO BE OF INFECTIOUS ORIGIN, WHEREIN THE AORTIC WALL BECAME DILATED (ANEURYSMATIC) RIGHT AT THE IMPLANT AND HAS MOVED THE IMPLANT AWAY FROM ITS ORIGINAL LOCATION. PSEUDOANEURYSMS ARE ALSO KNOWN TO OCCUR WITH HAND-SEWN ANASTOMOSES. THE VACUUM UTILIZED TO FACILITATE WOUND HEALING MAY HAVE BEEN A CONTRIBUTORY CAUSE OF THE ANEURYSM.

    Description of Event or Problem · 1

    A (B) (6) FEMALE PT OPERATED IN (B) (6) 2009, UTILIZING THREE PAS-PORT DEVICES DURING CABG PROCEDURE. PT HAD SEVERE STERNAL WOUND INFECTION AND WAS RE-ADMITTED TO HOSP (B) (6) 2010. CAT SCAN REVEALED THE PRESENCE OF AORTIC PSEUDOANEURYSM. CATH SHOWED ENTRY INTO PSEUDOANEURYSM WITH IMPLANT ATTACHED TO THE FALSE LUMEN. DUE TO CONCERNS ABOUT REOPERATIONS (STERNAL INFECTION) THE DECISION WAS MADE TO REPAIR THE HOLE WITH A 12MM AMPLATZER SEPTAL OCCLUDER DEVICE. DEPLOYMENT WAS SUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention