3f Enable Aortic Bioprosthesis (model 6000)

Related information

Hazard alert - potential for valve to move after implantation

23 November 2014

Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, has issued a hazard alert for its 3f Enable Aortic Bioprosthesis (model 6000). Medtronic Australasia is also undertaking a recall for product correction to update the Instructions for Use (IFU) for this device.

The 3f Enable Aortic Bioprosthesis is an artificial valve used to replace narrowed or regurgitant aortic heart valves.

This device is not entered in the Australian Register of Therapeutic Goods but has been supplied in Australia under the Special Access Scheme, by an Authorised Prescriber or as part of a clinical trial.

It has been identified that there is the potential for the 3f Enable Aortic Bioprosthesis to move after implantation, including partial or complete displacement or tilting from its original implant location.

Reports of this happening are rare and are most likely to occur and be identified during or immediately after implantation. If it does happen, a patient could require additional surgery. In worst case scenarios, a patient could experience serious heart problems.

To address this issue, Medtronic Australasia is updating the IFU for 3f Enable Aortic Bioprosthesis with guidelines and warnings and has provided interim instructions and training materials to relevant health professionals to reduce the risk.

Information for consumers

Medtronic Australasia has written to cardiologists and surgeons to provide further information about this issue, including instructions and training materials designed to reduce the risk of a valve moving after implantation.

The likelihood of this problem occurring is rare, with an occurrence rate of less than 0.55% globally (as of 31 October 2014).

If you, or someone you care for, have received an aortic bioprosthesis and experience any suspected signs or symptoms of heart problems, or if you are concerned about this issue, contact your cardiologist or surgeon.

Information for health professionals

Medtronic Australasia has written to cardiologists and surgeons to provide further information about this issue, including instructions and training materials designed to reduce the risk of a valve moving after implantation.

If you are treating a patient who has received an aortic bioprosthesis, reassure them that the likelihood of this problem occurring is rare, with an occurrence rate of less than 0.55% globally (as of 31 October 2014).

Be alert to the issue in your clinical decision-making and consider referring the patient to their cardiologist or surgeon, if required.

Information for cardiologists and surgeons

Cardiologists and surgeons are advised to perform an echocardiogram on all patients who receive a 3f Enable Aortic Bioprosthesis prior to discharge, as well as perform routine patient follow-up, including physical exam.

Medtronic Australasia recommends that two guiding sutures be used during implantation rather than one, as noted in the current IFU. Instructions regarding this recommendation have been provided to cardiologists and surgeons. If you have not received these materials, or have any questions or concerns about this issue, contact your Medtronic Australasia representative.

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.