FDA MedWatch – Valiant Navion Thoracic Stent Graft System by Medtronic:

TOPIC: Valiant Navion Thoracic Stent Graft System by Medtronic: Class I Recall – Due to Risk of Stent Fractures and Type III Endoleaks

AUDIENCE: Patient, Health Professional, Risk Manager

ISSUE: 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 fracture, and seven cases of stent ring enlargement. Some patients experienced multiple findings.

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: 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.

RECOMMENDATION: 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.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.