MEDTRONIC MISSION STATEMENT

Medtronic voluntarily initiated a recall of the Medtronic Valiant Navion™ Thoracic Stent Graft System and informed physicians to immediately cease use of the device in new patients as of February 2021. The recall was initiated because Medtronic, in consultation with external experts, discovered that some patients with these devices may develop a leak between the stent graft and the aorta.  A “recall” does not mean that the manufacturer is asking that patients have the device removed.

For patients who already have this stent graft, such leaks are generally treatable and can usually be detected with Computed Tomography (“CT”) imaging. These leaks, if left untreated, can potentially lead to aneurysm rupture. Because of this, it is important that patients follow up regularly with their doctor to evaluate their health and the condition of their stent.  Routine, ongoing surveillance has always been recommended for all patients who receive the Valiant Navion Thoracic Stent Graft System.  The earlier a leak is detected, the sooner it can be evaluated for potential treatment.  At this time, we are recommending patients seek routine CT imaging with contrast by your doctor every 6 months– unless your doctor decides this is not appropriate based on your individual medical situation. 

Medtronic is working diligently to assess the causes of the issues observed with the Valiant Navion Thoracic Stent Graft System but has not yet determined the root cause of this issue.  Preliminary analysis suggests the potential for a leak to develop between the stent graft and the aorta, which could lead to aneurysm rupture. Medtronic will make further updates as new information becomes available. 

Medtronic is following up with physicians to recommend that they closely evaluate and monitor patients implanted with these stent grafts. Potential leaks are generally treatable and can usually be detected with Computed Tomography (“CT”) imaging. These leaks, if left untreated, can potentially lead to aneurysm rupture. It is important that you follow up regularly with your doctor to evaluate your health and to monitor your ongoing care. The earlier a leak is detected, the sooner it can be evaluated and potentially treated.  

We recognize this may be concerning for you. Any leaks that may develop are generally treatable and can usually be detected with Computed Tomography (CT) imaging, but if left untreated, can potentially lead to aneurysm rupture. Please contact your doctor. It is important that you follow up with your doctor regularly to evaluate your health and monitor your stent graft and ongoing care.  

Contact your doctor who is the best resource for you to ask about your Medtronic device and what it may mean to you and your and ongoing care and monitoring. 

Based on the totality of the currently available  data and in consultation with an Independent Physician Quality Panel (IPQP), Medtronic updated its recommendation that patients implanted with Valiant Navion Thoracic Stent Graft have computerized tomography (CT) imaging with contrast every six (6) months or as frequently as deemed appropriate in your physician’s medical judgment.

There are no specific symptoms associated with early stent issues, which is why we have updated existing imaging guidance recommending patients seek CT imaging with contrast by their doctor every six (6) months, or as frequently as deemed appropriate in the physician’s medical judgment. If you believe you may have experienced a complication with your stent, please contact your doctor immediately.

As part of our commitment to patient safety, Medtronic is developing a patient and physician support program and may provide financial assistance to physicians and their eligible patients to support the recommendation for more frequent follow-up imaging. To verify eligibility, and to improve its ongoing technical investigation and patient recommendations, Medtronic may request access to certain medical records, including imaging results.  

Your doctor is the best resource for you to ask about your Medtronic device and what it may mean to you and your ongoing care. 

A “recall” does not mean that the manufacturer is asking that patients have the device removed.  With this recall, Medtronic informed physicians to immediately cease use of the device in new patients.  For patients who already have the device, it is important that you and your doctor review your individual medical situation together and determine an appropriate plan for you and your treatment moving forward.