Medtronic Valiant Navion Thoracic Stent Graft System Recall Issued Due To Endoleaks and Fractures

Federal health officials are warning about problems with Valiant Navion thoracic stent grafts, which may fracture and cause serious bleeding problems, known as endoleaks, potentially resulting in the need for additional surgeries and presenting increased health risks for patients.

In a Valiant Navion Thoracic Stent Graft System recall notice posted on April 9, the FDA instructs physicians to stop using the devices immediately, following at least 11 reports of the devices failing, resulting in at least one patient death.

Medtronic’s Valiant Navion Thoracic Stent Graft Systems are used to repair lesions and thoracic aortic aneurysms located in the body’s largest artery, the aorta. The devices allow a surgeon to use a catheter to place a stent inside of the aorta, which then expands to create a new blood flow path from the heart to the lower part of the body.

However, following implantation Medtronic has become aware patients can experience stent fractures, the stent ring expanding beyond design specification, and endoleaks due to holes in the fabric which, if not detected and left untreated, may cause life-threatening bleeding events.

To date, Medtronic and the FDA have received 11 reported issues involving the graft systems, including four cases of Type III endoleaks, four cases of stent factures, and seven cases of stent ring enlargements. Of the incidents, one patient died and two suffered serious injuries.

Officials warn Type III endoleaks could lead to thoracic aortic aneurysms and a rupturing hazard.

Patients who experience a rupture of the aneurysm sac require immediate medical intervention which may include re-lining, insertion of additional stent graft components, or open surgical repair which could increase the risk of morbidity.

Medtronic sent an Urgent Medical Device Recall notification on February 12, instructing physicians to stop using the Valiant Navion Thoracic Stent Graft System immediately and to closely monitor patients for adverse reactions.

Since the February notice, the FDA has given the recall a Class I designation, indicating it is the most serious of its kind and that there is a high probability the use of the device may result in serious and potentially life threatening health consequences.

The FDA is urging medical professionals to be cautious of the risks and to schedule at least annual follow-up evaluations with patients and to report any adverse events. Health complications linked to graft systems, such as Type III endoleaks, should be reported to the FDA’s MedWatch adverse event reporting system.