Promus Element Plus Monorail everolimus-eluting coronary stent system

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Recall for product correction - incorrect Directions for Use

30 July 2013

Consumers and health professionals are advised that Boston Scientific, in consultation with the TGA, has initiated a recall for product correction for multiple lots of its Promus Element Plus Monorail everolimus-eluting coronary stent system. Image of Prmus Element Plus Monorail everolimus-eluting coronary stent systemCardiologists and hospitals have been advised of the specific affected lots and a related hazard alert has been issued to cardiologists.

It has been identified that Promus Element Plus Monorail everolimus-eluting coronary stent systems have been shipped from the Australian distribution centre with incorrect Directions for Use (DFU).

Promus Element Plus Monorail everolimus-eluting coronary stent system is a medical device used to treat patients who have coronary artery disease. The stent is placed in a coronary artery to widen and keep the artery open. The stent also slowly releases a medicine, everolimus, which helps prevent the stented artery from becoming blocked again.

Information for consumers

Please note that Promus Element Plus Monorail everolimus-eluting coronary stent systems are not being recalled from the market, the issue is only in regard to the DFU and not the stent itself.

Boston Scientific has written to cardiologists who have implanted Promus Element Plus Monorail everolimus-eluting coronary stent systems, providing further information about this issue.

If you have had a coronary stent implanted and have any questions or concerns about this issue, please contact your cardiologist or the hospital where the procedure was performed.

Information for all health professionals

Patients who have had a coronary stent implanted and who have any questions or concerns about the above issue should be referred to their cardiologist or the hospital where the procedure was performed.

Information for cardiologists

Boston Scientific has written to cardiologists who have implanted Promus Element Plus Monorail everolimus-eluting coronary stent systems, providing further information about this issue and a copy of the correct DFU.

Ongoing treatment of patients who have received a Promus Element Plus Monorail everolimus-eluting coronary stent system should be conducted in accordance with the information contained in the correct Australian DFU, with specific reference to the section on 'Pre- and Post-Procedure Antiplatelet Regimen' (page 6, section 5.9).

If you or a patient have any questions or concerns, please contact your local Boston Scientific 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.

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