BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION OVER-THE-WIRE STENT

    MDR report key: 2133329 · Received June 9, 2011

    Report

    Report Number
    2133329
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    STENT CAME OFF OF DELIVERY SYSTEM AND A SNARE DEVICE WAS SUCCESSFULLY USED TO RETRIEVE THE STENT.======================MANUFACTURER RESPONSE FOR ION OVER THE WIRE STENT, ION OVER-THE-WIRE STENT 2.25 X 12MM (PER SITE REPORTER): REP WAS IN CATH LAB AT TIME OF EVENT: UNKNOWN RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION OVER-THE-WIRE STENT ION OVER THE WIRE STENT NIQ BOSTON SCIENTIFIC 39023-1222 14008114

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR