BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAS.PORT PROXIMAL ANASTOMOSIS SYSTEM

    MDR report key: 1373386 · Received May 1, 2009

    Report

    Report Number
    3004114958-2009-00004
    Event Type
    Injury
    Date Received
    May 1, 2009
    Date of Event
    April 3, 2009
    Report Date
    April 3, 2009
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    PMA / PMN Number
    K081225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE SURGEON, THE PATIENT'S CARDIAC FUNCTION WAS IMPROVING AFTER SURGERY. DURING THE COURSE OF INVESTIGATION, IT WAS REPORTED THAT THE PATIENT HAD EXPIRED ON POST-OPERATIVE DAY 8 OF CONGESTIVE HEART FAILURE.

    Description of Event or Problem · 1

    PAS-PORT SYSTEM WAS USED IN REDO-CABG IN 2009. THE PT HAD UNDERGONE TRIPLE BYPASS PROCEDURE BACK IN 2006 AND THERE WAS SOME CALCIFICATION IN THE ASCENDING AORTA. THERE WAS A TEAR OF THE RIGHT VENTRICLE DURING CHEST OPENING. THE PROCEDURE WAS CONVERTED TO ON-PUMP BEATING. PAS-PORT WAS USED ON AN AREA WHERE THERE WAS THOUGHT TO BE NO CALCIFICATION AND WHERE ADVENTITIA HAD BEEN REMOVED PARTIALLY DURING TISSUE DISSECTION. THE DEVICE FUNCTIONED AS NORMAL. AT THE POINT OF AORTOTOMY, THE AORTIC WALL RUPTURED AND BLOOD PRESSURE WENT DOWN IMMEDIATELY TO 25MMHG SYSTOLIC. THE SURGEON ALLEGES THAT THE IMPLANT HAD FORMED ON THE LATERAL WALL. THE ANTERIOR WALL RUPTURED AND COLLAPSED, THE IMPLANT FORMATION TOOK PLACE AT THE INTRA-LUMENAL LEVEL. THE DISSECTED AORTA WAS REMOVED AND REPAIRED BY AORTIC GRAFT REPLACEMENT UNDER CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAS.PORT PROXIMAL ANASTOMOSIS SYSTEM CARDIOVASCUALR SURGICAL INSTRUMENT FZP CARDICA, INC. NA 80605D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention