Immediate action Action Update Information request

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1 Safeguarding public health MEDICAL DEVICE ALERT Issued: 19 July 2006 at 15:00 Ref: MDA/2006/040 Immediate action Action Update Information request Device: Cardiac atrial septal occluder AMPLATZER, AGA Medical. Problem: Haemodynamic compromise associated with incorrectly sized occluder. Action by: Interventional cardiologists. Action: When implanting this device: Measure the defect diameter using echocardiographic imaging prior to balloon sizing. Perform balloon sizing. Do not use the pull technique. When using the 'stop flow' technique do not inflate the balloon beyond the cessation of the shunt. When using the stretch technique do not inflate the balloon beyond the point where a small waist is visible. Never over inflate the balloon. Select a device which is equal to or one size larger than the defect (as determined by balloon sizing). Do not select a device greater than 1.5 times the defect diameter (as determined by echocardiography prior to balloon sizing). In addition, follow the guidance in the manufacturer s technical note on patient selection, follow-up and education (see page 4 of the attached Appendix). Distributed to: NHS trusts in England Healthcare Commission (CHAI) Chief Executives* Headquarters * via CE Bulletin Contacts: Details of manufacturer/supplier contacts and MHRA contacts for technical and clinical aspects. Change of address or removal from address list for Healthcare Commission. Appendix: AGA Medical technical note. Page 2 Page 2 Pages 2-3 Page 4-7 Action deadlines for the Safety Alert Broadcast System (SABS) Deadline (action underway) : 04 August 2006 Deadline (action complete): 22 September 2006 This notice is also on our website: Medicines and Healthcare products Regulatory Agency Page 1 of 7

2 Issued: 19 July 2006 at 15:00 Ref: MDA/2006/040 Problem: On-going review by AGA Medical s panel of experts of incidents of haemodynamic compromise associated with the AMPLATZER septal occluder identified a common trend of occluder over-sizing. Between February 1998 and December 2005 AGA Medical received 37 reports of haemodynamic compromise, an incidence of 0.11% or approximately 1 in 1,000. AGA Medical issued the attached technical note (see Appendix) to their customers earlier this year providing information to interventional cardiologists on minimising the risk of tissue erosion and haemodynamic compromise. It gives recommendations on the correct device sizing and patient follow-up/education. AGA Medical plan to modify the device instructions for use to include relevant information along with training material and updated guidance. The review findings confirmed that for most patients the anterior/superior atrial free wall (right or left) is in close contact with the device edge(s), especially at the aortic/superior rim. If the device is oversized, the aorta compresses the waist of the device (not the discs) which stretches the atrial free wall over the device discs and the device edge may erode the free wall/aorta causing haemodynamic compromise. Tissue erosion is more likely to occur if the diameter of the device is greater than 1.5 times the diameter of the defect. Distribution: Please bring this notice to the attention of all who need to know or be aware of it. This will include distribution by: Trusts to: SABS liaison officers for onward distribution to all relevant staff including: Cardiovascular surgeons (for information) Cathlab managers Clinical governance leads Interventional cardiologists Interventional radiologists (for information) Medical directors Risk managers Supplies managers Theatre managers Healthcare Commission (CHAI) to: Headquarters for onward distribution to: Hospitals in the independent sector Private hospitals Contacts: Enquiries to the manufacturer/supplier should be addressed to: Manufacturer AGA Medical Corporation 628 Mendelssohn Avenue Golden Valley Minnesota MN USA Supplier BVM Medical Trinity Lane Hinckley Leicestershire LE10 0BL Tel: Fax: jraus@amplatzer.com Tel: Fax: hitesh@bvmmedical.com Medicines and Healthcare products Regulatory Agency Page 2 of 7

3 Issued: 19 July 2006 at 15:00 Ref: MDA/2006/040 Contacts (continued): Enquiries to the MHRA should quote reference number 2006/004/019/061/011 and be addressed to: Technical aspects: Mr Alexander McLaren, or Ms Sam Baxter Medicines & Healthcare products Regulatory Agency Market Towers 1 Nine Elms Lane London SW8 5NQ Tel: / 3242 Fax: alexander.mclaren@mhra.gsi.gov.uk sam.baxter@mhra.gsi.gov.uk Clinical aspects: Dr Susanne Ludgate Medicines & Healthcare products Regulatory Agency Market Towers 1 Nine Elms Lane London SW8 5NQ Tel: Fax: susanne.ludgate@mhra.gsi.gov.uk Change of address or removal from address list for Healthcare Commission: Healthcare Commission Finsbury Tower Bunhill Row London EC1Y 8TG Tel: contacts@healthcarecommission.org.uk How to report adverse incidents Incidents relating to medical devices must be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) as soon as possible. Further information about reporting incidents; on-line incident reporting facilities; and downloadable report forms are available from MHRA's website ( Alternatively, further information and printed incident report forms are available from: MHRA Adverse Incident Centre Medicines and Healthcare products Regulatory Agency Market Towers, 1 Nine Elms Lane, London SW8 5NQ Telephone or Fax or aic@mhra.gsi.gov.uk (An answerphone service operates outside normal office hours) Medical Device Alerts are available in full text on the MHRA website: Further information about SABS can be found at MHRA is an executive agency of the Department of Health Crown Copyright 2006 Addressees may take copies for distribution within their own organisations Medicines and Healthcare products Regulatory Agency Page 3 of 7

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