Device Intracranial stent: SILK artery reconstruction device manufactured by Balt Extrusion and distributed in the UK by Pyramed Ltd.
Problem Action Potential for patient death if the device is used Do not use the SILK device without to treat intracranial aneurysms without using embolisation coils. 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 e.g. CTA/MRA; Action by • assess the status of the aneurysm at Interventional neuroradiologists. 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.
Medicines and Healthcare products Regulatory Agency Page 1 of 4
Issued: 23 March 2010 at 14:30 Ref: MDA/2010/023
Device All SILK artery reconstruction devices are affected by this notice. This device is indicated for treating intracranial aneurysms.
Problem 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.
Distribution 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)
Onward distribution Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by: Trusts to: CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including: • Clinical governance leads • Heads of radiology • Interventional neuroradiologists • Medical directors • Neurologists • Neurosurgeons • Purchasing managers • Risk managers • Supplies managers • Theatre managers • Theatres
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
Medicines and Healthcare products Regulatory Agency Page 2 of 4
Issued: 23 March 2010 at 14:30 Ref: MDA/2010/023
Contacts Supplier Clive Noel Pyramed Ltd. Unitech House Unit B1-B2, Bond Close Kingsland Business Park Basingstoke Hampshire RG24 8PZ Tel: 01256 365 454 Fax: 01256 365 486 Email: [email protected] Manufacturer Eric Largen Balt Extrusion 10 rue de la Croix Vigneron 95160 Montmorency France Tel: +33 139 34 61 84 Fax: +33 134 17 03 46 Email: [email protected]
England If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/023 or 2009/012/003/401/010 Technical aspects Clare Huntington or Sarah Debenham Medicines & Healthcare products Regulatory Agency Market Towers 1 Nine Elms Lane London SW8 5NQ Tel: 020 7084 3163/3264 Fax: 020 7084 3106 Email: [email protected] [email protected]
Clinical aspects Dr Susanne Ludgate Medicines & Healthcare products Regulatory Agency Market Towers 1 Nine Elms Lane London SW8 5NQ Tel: 020 7084 3123 Fax: 020 7084 3111 Email: [email protected]
How to report adverse incidents
Please report via our website http://www.mhra.gov.uk Further information about CAS can be found at https://www.cas.dh.gov.uk/Home.aspx
Medicines and Healthcare products Regulatory Agency Page 3 of 4
Issued: 23 March 2010 at 14:30 Ref: MDA/2010/023
Northern Ireland Alerts in Northern Ireland will continue to be distributed via the NI SABS system. Enquiries and adverse incident reports in Northern Ireland should be addressed to: Northern Ireland Adverse Incident Centre Health Estates Investment Group Room 17 Annex 6 Castle Buildings Stormont Estate Dundonald BT4 3SQ Tel: 02890 523 704 Fax: 02890 523 900 Email: [email protected] http://www.dhsspsni.gov.uk/index/hea/niaic.htm
How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on our website http://www.dhsspsni.gov.uk/niaic Further information about SABS can be found at http://sabs.dhsspsni.gov.uk/
Scotland Enquiries and adverse incident reports in Scotland should be addressed to: Incident Reporting and Investigation Centre Health Facilities Scotland NHS National Services Scotland Gyle Square 1 South Gyle Crescent Edinburgh EH12 9EB Tel: 0131 275 7575 Fax: 0131 314 0722 Email: [email protected] http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/
Wales Enquiries in Wales should be addressed to: Dr Sara Hayes Senior Medical Officer Medical Device Alerts Welsh Assembly Government Cathays Park Cardiff CF10 3NQ Tel: 029 2082 3922 Email: [email protected]
MHRA is an executive agency of the Department of Health
Delta Module Two Lsa 3 - Part One SYSTEMS: Helping Lower Levels To Understand and Use High Frequency Phrasal Verbs Khara Burgess Lord Byron College Centre No: It295
