The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Medtronic Valiant Navion Thoracic Stent Graft System
- Model Number, Product Codes, Catalog or Lot numbers: Please See Links Below.
- Distribution Dates: November 12, 2018 to February 10, 2021
- Devices Recalled in the U.S.: 14,237
- Date Initiated by Firm: February 4, 2021
The Valiant Navion Thoracic Stent Graft System is designed to repair lesions of the descending thoracic aorta, located in the body’s largest artery (aorta) which passes through the lower part of the chest. A surgeon uses a long tube-like device (catheter) to place the stent graft inside the aorta. Once placed, the stent expands to fit within the aorta to provide a new path for blood to flow from the heart to the lower part of the body.
Reason for Recall
Medtronic is recalling the Valiant Navion Thoracic Stent Graft System due to stent fractures and endoleak concerns. Following device implantation, patients may experience stent ring enlargement beyond design specification, stent fractures, holes in the graft fabric (Type III endoleaks), life-threatening bleeding, aortic rupture, or death.
There have been 11 reported issues related to this device including two injuries and one death. There have been four cases of Type III endoleak, four cases of stent facture, and seven cases of stent ring enlargement. Some patients experienced multiple findings.
Who May be Affected
- Health care providers using the affected Medtronic device
- Patients who were implanted with the affected Medtronic device
What to Do
On February 12, 2021, Medtronic sent an Urgent Medical Device Recall notification to all affected customers. Recommendations were offered to help physicians and patients evaluate the risks of the device.
- 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.
Patients with an implant card after surgery for the Medtronic Valiant Navion Thoracic Stent Graft System should consult their physician with any questions.
Customers with questions about this recall should contact Medtronic Customer Service at 1-888-283-7868.
Full List of Affected Devices
How to report a problem
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.