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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