BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

    MDR report key: 2269094 · Received September 9, 2011

    Report

    Report Number
    3004114958-2011-00005
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    PMA / PMN Number
    K081225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONAL RESULTS / CONCLUSION: THE DEVICE WAS RETURNED WITH THE KNOB ROTATED APPROX 270 DEGREES. THE CARTRIDGE AND EXPANDER CROWN ASSEMBLY HAD BEEN REMOVED FROM THE DEVICE. THE EXPANDER CROWN ASSEMBLY HAD BEEN BROKEN, WITH THE CROWN SNAPPED OFF. THE IMPLANT IS STILL ATTACHED TO THE EXPANDER. IT HAS BEEN CRUSHED AND THE DAMAGE MADE IT DIFFICULT TO DETERMINE THE EXTENT TO WHICH THE IMPLANT HAD FORMED. BASED ON THE SATE OF THE RETURNED DEVICE AND THE DESCRIPTION OF EVENTS, THIS APPEARS TO BE A SLIP-OFF. IT IS POSSIBLE THAT A THICK OR INELASTIC VEIN MAY HAVE CONSTRAINED THE INNER TINES, IMPEDING THEIR FORMATION. THIS IN TURN COULD HAVE RESULTED IN THE SLIP-OFF EVENT, WHERE THE EXPANDER TIP WAS ABLE TO GO THROUGH ITS MOTION BUT DID NOT CONNECT WITH THE IMPLANT HORNS. FUNCTIONAL TESTING OF THE DEVICE WAS SUCCESSFUL AND THE COMPLAINT COULD NOT BE REPLICATED.

    Description of Event or Problem · 1

    THIS PAS-PORT DEVICE, WITH A SECOND PAS-PORT REPORTED IN 3004114958-2011-0004, WAS ONE OF TWO USED IN A ROBOTIC CORONARY ARTERY BYPASS GRAFT SURGERY. THE PAS-PORT DEPLOYED BUT THE INNER TINES DID NOT FORM. THE DEVICE KNOB APPEARED DIFFICULT TO TURN. THE DEVICE WAS EXPLANTED AND THE ANASTOMOSIS WAS HAND-SEWN. THE PT WAS REPORTED BY THE PHYSICIAN AS "DOING FINE" 1-1/2 WEEKS AFTER THE SURGERY DATE. THE DEVICE WAS RETURNED FOR TESTING. NO FAILURE COULD BE REPLICATED. THE DEVICE FIRED AND DEPLOYED NORMALLY IN ARTIFICIAL MEDIA. THE ANALYSIS SUGGESTS THAT THE GRAFT TISSUE MAY HAVE BEEN TOO THICK OR INELASTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM CLIP, IMPLANTABLE FZP CARDICA, INC. NA 100909C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention