BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2987657 · Received February 28, 2013

    Report

    Report Number
    3005325609-2013-00005
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K093893
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF SUBMISSION OF THIS MDR, IT WAS REPORTED THAT THE STENT IS STILL IN THE PATIENT'S BOWEL AND DID NOT PASS YET AS EXPECTED BY THE PHYSICIAN. THERE HAS BEEN NO ADVERSE EFFECTS TO THE PATIENT. THE CAUSE OF THE EVENT IS INCONCLUSIVE. THERE WAS NO DEFECT OF THE DELIVERY SYSTEM FOUND THAT COULD BE ATTRIBUTED TO THE EVENT. IT IS POSSIBLE THAT THE STENT WAS UNDERSIZED FOR THE TARGET BILIARY DUCT.

    Description of Event or Problem · 1

    THE STENT WAS DEPLOYED INTO THE BILIARY DUCT AND MIGRATED FORWARD INTO THE PATIENT'S BOWEL. THERE WAS NO ADVERSE EFFECT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86606 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-08-040-120-G3 06116052

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR