Medical Device Alert: Intracranial stent manufactured by Balt Extrusion (MDA/2010/023)

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: clare.huntington@mhra.gsi.gov.uk or sarah.debenham@mhra.gsi.gov.uk

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: susanne.ludgate@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices.
Further information about CAS can be found on the Central Alerting System website (external link).

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: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).
Further information about SABS can be found on the SABS website (external link).

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: nss.iric@nhs.net

Health Facilities Scotland - Incident Reporting and Investigation Centre (external link).

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: Haz-Aic@wales.gsi.gov.uk

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)

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

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: clive.noel@pyramed.co.uk

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: quality.manager@balt.fr

If you have any comments or feedback on this Medical Device Alert, please email us at: dts@mhra.gsi.gov.uk