EvolutTM PRO+34mm Transcatheter Aortic Valve (TAV)

Medtronic Australasia is informing customers about the serious risk of valve infolding for EvolutTM PRO+ 34mm Transcatheter Aortic Valve (TAV), item code - EVPROPLUS-34US.

What is infolding?

Infolding occurs when the valve frame folds inward, preventing full expansion and function of the valve. Usually, this is detected during surgery by the doctors and can be corrected by removal of the valve and replacement with a new valve, or post-implant dilatation.

In some cases, the infolding was not detected until after the procedure.

Information for patients

Medtronic Australasia has written to clinicians and surgeons who have implanted the Evolut PRO+34mm Transcatheter Aortic Valve providing further information about infolding and advice on how to treat affected patients.

If you have a Evolut PRO+34mm Transcatheter Aortic Valve implanted and have any questions or concerns regarding this device, please contact your surgeon or the hospital where you had the surgery.

Information for Healthcare Professionals

Patients who have been treated with an Evolut PRO+ 34mm can continue to be managed according to standard patient management protocols and do not require any additional management.

• The Evolut PRO+ 34mm has been supplied in Australia through the Special Access Scheme (SAS)
• As a result of the infolding issue, Medtronic is advising this device will no longer be accessible via the SAS pathway
• The TGA recommends clinicians utilise transcatheter aortic valves that are included on the Australian Register of Therapeutic Goods (the ARTG) which can be used to treat the same patient population and do not display the infolding seen with Evolut PRO+
• Of note, further iterations of these devices, such as the Evolut FX, have not yet been evaluated for safety and performance by the TGA.

What are the risks?

At least 9 deaths overseas have occurred due to valve infolding.

Other serious adverse events were also experienced as below:

• unplanned surgery/intervention to fix the issue
• aortic regurgitation/insufficiency
• aortic root injury
• annular rupture
• myocardial infarction
• pacemaker insertion
• paravalvular leak
• hypotension
• congestive heart failure
• aortic dissection
• increased risk of stroke.

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.