Thoracic Stent Graft System Recalled by Medtronic after Patient Injuries and Death

Posted by Marianne C. LeBlanc

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Marianne is a trial attorney with over two decades of experience in representing clients and a member of BBO and served on the Regulators Subcommittee of the SJC Committee on Lawyer Well-Being. With record-setting verdicts in MA, Marianne’s advocacy skills draw on her commitment to making a difference both for clients and the community at large. Meet Marianne

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Medtronic PLC has just recalled their Valiant Navion™ thoracic stent graft system.

The global recall follows a review of data from the Valiant Evo Global Clinical Trial. The trial found three patients had stent fractures resulting from use of the device. Two patients also had confirmed rare type IIIb endoleaks, following aortic repairs. These occur when overlapping pieces of the graft separate, allowing blood to pass through the fabric of the graft.

Though rare, Type IIIb endoleaks can lead to aneurysm. They may also cause a rupture requiring immediate treatment. One patient death led to Medtronic’s global recall. An independent imaging lab also found seven of 87 patients had stent ring enlargement.

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