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Medtronic recently announced in an Urgent Medical Device Recall that it was recalling all unused Medtronic Valiant Navion Thoracic Graft Systems around the world. The company informed physicians to immediately cease use of the device until further notice.

Medtronic Recalls Graft System After Receiving Reports of Leakage

Medtronic initiated this recall in response to the results of a recent study where a total of 100 patients were enrolled in the Valiant Evo Global Clinical Program, in which doctors analyzed the performance of the Valiant Navion Thoracic Stent Graft System.

Of those 100 patients, three suffered from stent fractures, of which two were found to have confirmed Type III(b) endoleaks. These leaks, if left untreated, can potentially lead to aneurysm rupture. One of the patients died because of this problem.

An independent imaging lab also reviewed all available images from patients enrolled in the trial and found that seven out of 87 had stent ring enlargements.  These ring enlargements were out of the stent ring specifications potentially harming the individuals.

Medtronic also received two complaints about patients treated outside this clinical trial with the same stent graft system:

  1. One was treated for a type III(b) endoleak
  2. One was treated for a type III(b) endoleak with stent fracture

These two complaints were reported out of about 14,000 patients treated with the Valion Navion thoracic stent graft globally. Medtronic performed an explant analysis on the first complaint and confirmed no stent-graft defects. The device related to the second complaint is still implanted in the patient, so Medtronic couldn’t confirm whether the stent was fractured.

Medtronic stated it was currently conducting a comprehensive technical root cause investigation to determine what might have caused these issues. Meanwhile, it has implemented a global recall of the products, asking doctors to identify and quarantine all unused stent graft systems, and to return all of them to Medtronic. It also advised doctors to review all available images of patients treated with the system to look for any stent fractures or endoleaks.

What is the Medtronic Valiant Navion Thoracic Stent Graft System?

The U.S. Food and Drug Administration (FDA) also announced the Medtronic recall and advised patients with a Medtronic Valiant Navion Thoracic Stent Graft System to talk to their doctors about any of their concerns.

According to Medtronic, the Valiant Navion system is designed to treat problems with the thoracic aorta, which is a section of the aorta (the largest artery in the body) within the chest. This artery carries oxygen-rich blood away from the heart to all parts of the body.

The thoracic aorta is the part of the aorta that runs through the chest and down to the abdomen, whereupon it becomes the abdominal aorta.

Medtronic’s graft system can be used to treat the following:

  • Thoracic aortic aneurysms
  • Type B aortic dissection
  • Intramural hematoma (blood leaking through the innermost layer of the aortic wall)
  • Penetrating atherosclerotic ulcer (plaque in the aorta forms ulcers)
  • Blunt thoracic aortic injury (usually a life-threatening injury to the thoracic aorta)

With the Valiant Navion stent graft system, doctors can perform a minimally invasive procedure to repair the damaged aorta.

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