Follow @TheHPRA
Contact us
As Gaeilge
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
Medical Devices
Safety Information
Safety communications
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
COVID-19 Updates
Our role
Safety Information
Reporting safety issues
Monitoring device safety
Safety communications
About HPRA Safety Notices
Manufacturer's Field Safety Notices
User Engagement
Consumer advice
Regulatory Information
Registration
Medical Devices News & Events
Special Topics
Contact Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
Intracranial Stent SILK
Notice type:
Advisory
Date:
14/06/2010
Product name or type:
Intracranial Stent SILK
Reference:
SN2010(06)
Manufacturer Or Supplier:
Balt Extrusion
Target Audience:
Neuroradiologists
Problem Or Issue:
Potential for patient death if the device is used to treat intracranial aneurysms without using embolisation coils.
Background Information Or Related Documents:
The manufacturer (Balt Extrusion, France) issued an urgent field safety notice on 09 March 2010 advising the affected customers they are aware of reports of patient deaths associated with the use of the SILK device (please see the attached field safety notice). 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 giant intracranial aneurysm (18 to 31mm) and without the use of additional embolisation coils.
The manufacturer advised 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.
The manufacturer has notified the Irish Medicines Board (IMB) that they recommend the following actions are taken for the follow up of the patients:
The manufacturer has notified the Irish Medicines Board (IMB) that they recommend the following actions are taken for the follow up of the patients:
• Identify patients who have been implanted with the SILK device without
embolisation coils.
• Assess the status of the aneurysm at approximately 3 months post implant by a non-invasive technique, e.g. Computed Tomography Angiography (CTA), Magnetic Resonance Angiography (MRA)
• Assess the status of the aneurism at approximately 6 months post implant by an invasive technique, e.g. angiography.
• Insert a further stent if the aneurysm status is unsatisfactory at these times.
• The users can contact Dr Kulcsar (tel. 00.41.44.63.53800), neuroradiologist in
Zurich, who collects and analyses the post implantation complications with
the Silk device.
Intracranial Stent SILK Document
Actions To Be Taken:
• Ensure the appropriate personnel are made aware of this notice.
• Ensure that the patient follow up recommended by the manufacturer is followed (please see above).
Further Information:
All adverse incidents relating to a medical device should be reported to the:
Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Telephone: +353-1-6764971
Fax: +353-1-6344033
Enquiries should be addressed to:
Manufacturer:
Balt Extrusion
10 rue de la Croix Vigneron
95160 Montmorency
France
Telephone: +33 139 34 61 84
Fax: +33 134 17 03 46
Email:
quality.manager@balt.fr
Contact person: Eric Largen / Aude Chapuis-Hardy
Click Here to download Field Safety Notice
Click Here to download Safety Notice
« Back
Date Printed: 20/04/2024