Medtronic Valiant Navion

Main article: Defective and dangerous Medtronic products

2021: Withdrawal of defective aortic stents that break

In early April 2021, it became known that Medtronic was withdrawing the defective aortic stents of Valiant Navion, which were breaking down. Recall was classified as Grade I, the most serious, as defective devices can threaten a patient's life.

Valiant Navion is designed to restore blood flow down the thoracic aorta. To place the stent inside the aorta, a long catheter is used, and then the stent graft expands, expanding the sclerotic walls of the aorta and thereby providing normal blood flow from the heart to the lower body.

Medtronic initiated the recall of defective devices on February 4, 2021 in response to data obtained from the Valiant Evo International Clinical Study. According to this information, in three patients the stent broke, and in two cases endoleak was confirmed, that is, blood passed through the aneurysmal sac outside of the implant rods.

Medtronic Valiant Navion Stent

Secondary surgery to address this side effect in one of the patients was fatal. In the absence of autopsy, death was regarded as aortic rupture and recognized by an independent clinical events committee as aneurysm-related death as it occurred within 30 days of the secondary procedure (on the third day).

In total, 11 complaints were received regarding the new stent, including four cases of type III endothermia, four cases of stent fracture and seven cases of expansion of the stent ring. Some patients had several problems at the same time.

According to an FDA report, recalled devices were produced between November 12, 2018 and February 10, 2021. 14,237 devices were recalled in the United States. Doctors are advised to immediately stop using the Valiant Navion system and re-evaluate all available data from imaging examinations of patients who have already implanted this system.^[1]

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