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Important Medical Device Information For Medtronic Valiant Navion™ Thoracic Stent Graft System

Dear Patient:

As you would have been made aware from your physician, the Medtronic Valiant Navion™ Thoracic Stent Graft was recalled by Medtronic on February 17, 2021 with instructions to physicians to immediately cease use of the device in new patients. The recall is because Medtronic discovered that some patients with these devices developed a leak between the stent graft and the aorta.  A “recall” means that the manufacturer has asked physicians to stop using the device with new patients; it does not mean that patients have been asked to have the device removed.

You were provided this communication because your physician’s information shows you have a Medtronic Valiant Navion™ Thoracic Stent Graft implanted to treat your condition. For patients who have the device, these leaks are generally treatable and can usually be detected with Computed Tomography (“CT”) imaging.  The earlier a leak is detected, the sooner it may be treated. If left untreated, leaks can potentially lead to aneurysm rupture. For this reason, regular imaging is an important part of follow-up for all patients implanted with a Medtronic Valiant Navion™ Thoracic Stent Graft.

Since February, Medtronic has updated your physician to recommend more frequent imaging, considering conducting routine CT imaging with contrast of your stent every 6 monthsOf course, your doctor may have individualized patient recommendations about whether or when you need imaging, or what type of imaging, and Medtronic defers to your doctor in those considerations.

We recognize this may be concerning to you. Please contact your doctor to speak about what this new recommendation may mean for you and your ongoing care.

Medtronic will work with patients, physicians, and hospitals to address any unreimbursed medical expenses incurred due to the Valiant Navion recall. Costs that are directly related to patients’ medical care in connection with use of the Valiant Navion stent graft, including imaging, should be billed to the patients’ health insurance provider in the usual manner. In the event a claim is denied by insurance or the patient is uninsured, or if the patient has related out-of-pocket costs incurred in obtaining medical treatment directly related to the Valiant Navion recall (such as insurance co-payments, coinsurance, deductibles, travel expenses, incidentals, or other unreimbursed medical expenses), please contact the Valiant Navion Call Center at 1-833-256-2308 for assistance.

Medtronic is committed to patient safety and will update physicians with any new recommendations or information related to your stent graft. We know that the greatest promise we make is to consistently produce safe medical technologies that alleviate pain, restore health and extend life for patients.  We are committed keeping you informed, and continuously improving our products.

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What is the Valiant Navion™ Thoracic Stent Graft?

This stent graft (or stent as it’s commonly called) is a woven polyester tube (graft) supported by a strong but flexible metal frame (stent) and is used to support a weak spot in the aorta (the largest blood vessel in your chest). 

Why is Medtronic recalling the Valiant Navion thoracic stent grafts?

What exactly is the problem and what caused it?

How is Medtronic fixing this issue?

I was implanted with a Valiant Navion thoracic stent graft. Am I in danger?

What should I do?

Did the guidance for follow-up CT imaging change? How often should CT imaging be performed and are there any dangers from the imaging that I need to know about?

How will I know if I am having any trouble with my stent or am risk for a bleed/rupture?

Will Medtronic cover my medical expenses associated with this issue?

Is there someone at Medtronic I can contact about this?

Should I have the device replaced?