FDA Issues Class I Recall for Medtronic Valiant Navion Thoracic Stent Graft System
On April 9, 2021, the U.S. Food and Drug Administration (FDA) issued a Class I recall notice for the Medtronic Valiant Navion Thoracic Stent Graft System. An FDA Class I recall is the most serious type of recall and is only used when there is a reasonable probability that the use of a product will cause serious injuries or death.
The aorta is the largest artery in the body and is the main artery that carries blood directly from the heart. The thoracic aorta is the upper portion of the aorta that runs from the heart down through the chest. The Medtronic Valiant Navion Thoracic Stent Graft System is used in patients with a weakened or damaged thoracic aorta. The device is implanted into the thoracic aorta so that blood flows through the device instead of the weakened or damaged area.
Medtronic recalled the Valiant Navion devices after several reports of serious issues with the devices were received. The reports have included cases of Type III endoleaks, stent factures, and stent ring enlargement. Patients may experience life threatening bleeding, aortic rupture, or death. To date at least one death has been reported.
Medtronic is recommending that physicians:
- Immediately cease use of the stent graft system and follow instructions for returning unused products to Medtronic
- Review all available images of patients treated with the stent graft system and contact Medtronic if any findings are observed
- Follow best clinical practices and evaluate patients with at least annual follow-up
- Notify Medtronic of any adverse events or product safety issues associated with the device
Medtronic is also recommending that Patients implanted with a Medtronic Valiant Navion Thoracic Stent Graft System should consult their physician with any questions. Medtronic’s full recommendations can be found in its February 17, 2021 Urgent Medical Device Recall Notification Letter posted to its website.
If you are a loved one have suffered a Type III endoleak, stent fracture, or stent ring enlargement after being implanted with a Medtronic Valiant Navion Thoracic Stent Graft System, contact one of the experienced product liability attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call (800) 713-9340 or fill out our contact form for a FREE no-obligation consultation today.