Events

Field Safety Notices about IntraStent Unmounted Balloon Expandable Stent

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Ev3.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2008(01)
  • Date
    2008-01-24
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/intrastent-unmounted-balloon-expandable-stent&id=9699f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    The manufacturer, ev3, has advised the irish medicines board (imb) of a recall of specific lots of the intrastent unmounted balloon expandable stent.    the manufacturer has confirmed that the following affected lot / serial numbers have been supplied to the irish market:    4206244, 1688027, 1979986, 3003378.
  • Action
    Ensure that the relevant personnel in your organisation are made aware of this recall. Determine if you have purchased the affected lots of this product. Quarantine and return any unused affected product to ev3, United Kingdom office (see address below). Advise the IMB if you have the affected product.

Device

IntraStent Unmounted Balloon Expandable Stent
  • Model / Serial
    4206244, 1688027, 1979986, 3003378
  • Product Description
    IntraStent Unmounted Balloon Expandable Stent
  • Manufacturer
    Ev3

Manufacturer

Ev3
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HPRA