BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAS.PORT PROXIMAL ANASTOMOSIS SYSTEM

    MDR report key: 1396225 · Received May 29, 2009

    Report

    Report Number
    3004114958-2009-00005
    Event Type
    Injury
    Date Received
    May 29, 2009
    Date of Event
    May 1, 2009
    Report Date
    May 1, 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

    THE PAS-PORT IMPLANT MAY GO INTO THE INTRA-LUMEN OF THE AORTA IF EXCESSIVE PRESSURE IS APPLIED TO THE DEVICE DURING DEPLOYMENT OR IF THE AORTA IS NOT PRESSURIZED DURING THE PROCEDURE. THE PAS-PORT IFU CLEARLY STATES THAT THE PHYSICIAN MUST "ENSURE THERE IS FULL CONTACT BETWEEN THE DEVICE AND THE SURFACE OF THE TARGET VESSEL WITHOUT COMPRESSING OR INDENTING THE TARGET VESSEL" AND TO "ENSURE THAT THE MAIN ARTERIAL PRESSURE DURING DEPLOYMENT IS AT LEAST 50 MMHG". THE ACTUAL DEVICE USED IN THIS CASE WAS SENT BACK TO CARDICA IN 2009. THE DEVICE WAS INSPECTED AND TESTED. THIS DEVICE PASSED ALL SPECIFIED REQUIREMENTS.

    Description of Event or Problem · 1

    THE PATIENT HAD A DUODENAL ANEURYSM REQUIRING ANEURYSM REPAIR AND CELIAC ARTERY OCCLUSION REQUIRING ABDOMINAL AORTA-TO-CELIAC ARTERY BYPASS (USING SVG GRAFT), FOR WHICH PAS-PORT WAS UTILIZED. THE SURGEON REPORTED THAT A SEVERE HEMORRHAGE OCCURRED AT DEPLOYMENT AND THE IMPLANT WAS NOT VISIBLE. AFTER DEPLOYMENT, THERE WAS AN AORTOTOMY MADE AND THE SVG GRAFT ATTACHED TO THE IMPLANT COULD BE PULLED IN AND OUT. IT WAS REPORTED THAT THE IMPLANT WAS INTRA-LUMINAL. THE SURGEON DISSECTED THE AORTOTOMY AND REMOVED THE IMPLANT. AFTER REMOVING THE IMPLANT, THE ABDOMINAL AORTA WAS SUTURED TOGETHER AND THE BYPASS ANASTOMOSIS WAS HAND-SEWN NEAR THE INITIAL PAS-PORT DEPLOYMENT SITE. THE PATIENT WAS PUT ON PCPS AND PUT UNDER CARDIAC ARREST FOR THE RECOVERY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAS.PORT PROXIMAL ANASTOMOSIS SYSTEM CARDIOVASCULAR SURGICAL INSTRUMENT FZP CARDICA, INC. NA 80717E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention