Events

Safety Alert Or Field Safety Notices for Intracranial stent

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Balt Extrusion.

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
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2010/023
  • Date
    2010-03-23
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-intracranial-stent-don-t-use-to-treat-intracranial-aneurysms-without-embolisation-coils
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
    Potential for patient death if the device is used to treat intracranial aneurysms without using embolisation coils.The MHRA is aware of reports of patient deaths (including four in the UK) associated with the use of the SILK device. These fatalities occurred between 5 and 150 days after implantation.The causes of these deaths have not been conclusively determined. However, each of these patients had been treated for an existing large (15 to 25mm) or giant (25 to 50mm) intracranial aneurysm and without the use of additional embolisation coils.The manufacturer (Balt Extrusion, France) issued an urgent Field Safety Notice on 09 March 2010 advising that it does not currently have the clinical data to support the use of the SILK device without the use of embolisation coils.The manufacturer now intends to amend the instructions for use (IFU) to reflect this advice. It is also planning a post-market clinical trial to investigate the use of the SILK device without coils in aneurysms with a diameter less than 15mm.
  • Reason
    (balt extrusion) potential for patient death if you use any silk artery reconstruction device to treat intracranial aneurysms without embolisation coils. (mda/2010/023).
  • Action
    Do not use the SILK device without embolisation coils.Identify patients who have been implanted with the SILK device without embolisation coils and:assess the status of the aneurysm at approximately 3 months post implant by a non-invasive technique eg CTA/MRA assess the status of the aneurysm at approximately 6 months post implant by an invasive technique eg angiography insert a further stent if the aneurysm status is unsatisfactory at these times.

Device

Intracranial stent
  • Model / Serial
  • Product Description
    Intracranial stent: SILK artery reconstruction device manufactured by Balt Extrusion and distributed in the UK by Pyramed Ltd.All SILK artery reconstruction devices are affected by this notice.This device is indicated for treating tracranial aneurysms.
  • Manufacturer
    Balt Extrusion

Manufacturer

Balt Extrusion
  • Manufacturer Address
    Eric Largen Balt Extrusion 10 rue de la Croix Vigneron 95160 Montmorency France Tel: +33 139 34 61 84 Fax: +33 134 17 03 46Email: quality.manager@balt.fr
  • Manufacturer Parent Company (2017)
    Balt Extrusion
  • Source
    MHRA