Image of Intracranial stent: SILK artery reconstruction device packaging.
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.
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.
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.
This MDA has been distributed to:
NHS trusts in England (Chief Executives)
HSC trusts in Northern Ireland (Chief Executives)
NHS boards in Scotland (Chief Executives)
NHS boards and trusts in Wales (Chief Executives)
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
clinical governance leads
heads of radiology
Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:
hospitals in the independent sector
independent treatment centres
private medical practitioners
Clive Noel Pyramed Ltd.
Kingsland Business Park