Zenith Alpha thoracic endovascular graft

Consumers and health professionals are advised that William A Cook Australia, in consultation with the TGA, has issued a hazard alert for its Zenith Alpha thoracic endovascular graft. William A Cook Australia is also initiating a recall for product correction to update the Instructions for Use (IFU) for this device to reduce the risk of complications.

Zenith Alpha thoracic endovascular grafts are used to treat patients with aneurysms in a certain part of their aorta. The aorta is the largest artery in the body and runs down through the chest and abdomen.

Data collected during ongoing, longer-term follow-up of patients enrolled in a multi-national clinical investigation has led to additional warnings and precautions being added to the IFU to emphasise best practice and reduce the risk of complications.

Potential complications include distal type I endoleak, aneurysm growth and migration of the graft. Each of these complications may lead to an aneurysm rupturing, which can be life-threatening.

Information for consumers

William A Cook Australia has written to surgeons who have implanted Zenith Alpha thoracic endovascular grafts, providing further information about this issue.

As of 10 February 2015, there have been no reports of patients experiencing problems associated with this issue in Australia.

The benefits of this device continue to outweigh any risks associated with its use.

If you or someone you care for have received a thoracic endovascular graft, you are unlikely to experience a problem associated with this issue.

However, if you have any questions or concerns about this issue, contact your health professional.

Information for all health professionals

William A Cook Australia has written to surgeons who have implanted Zenith Alpha thoracic endovascular grafts, providing further information about this issue.

If you are treating a patient who has received a thoracic endovascular graft, reassure them that they are unlikely to experience a problem associated with this issue.

If they continue to have questions or concerns about this issue, refer them to their surgeon or the hospital where the operation was undertaken.

Information for surgeons

William A Cook Australia has written to surgeons who have implanted Zenith Alpha thoracic endovascular grafts advising that the IFU have been updated with additional warnings and precautions.

You should consider undertaking additional surveillance and provide extra treatment (if necessary) to patients who have already received a Zenith Alpha thoracic endovascular graft with a single proximal component and who have:

• a short distal sealing length
• graft length inadequate to maintain distal seal when settled into the greater curve of the aneurysm
• inadequate oversizing
• any other complications, including type I endoleak, aneurysm enlargement and migration of the graft.

Refer to the updated IFU before using this device for future patients.

If you have any questions or concerns about this issue, contact William A Cook Australia on 07 3434 6000.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.