FDA Names Recall of Valiant Navion Stent Graft as Class I

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The US Food and Drug Administration (FDA) has named Medtronic’s recent worldwide recall of unused Valiant Navion thoracic stent grafts as Class I, the label given to recalls of devices found to pose a potential risk for serious injuries or death, the agency announced today.

As previously reported, the company initiated the recall after reports of stent fractures and endoleaks in an international clinical trial.

On the basis of that experience, the FDA says, patients implanted with the stent grafts “may experience stent ring enlargement beyond design specification, stent fractures, holes in the graft fabric (Type III endoleaks), life-threatening bleeding, aortic rupture, or death.”

Eleven cases involving such issues have been reported, “including two injuries and one death,” the agency says. “There have been four cases of Type III endoleak, four cases of stent facture, and seven cases of stent ring enlargement. Some patients experienced multiple findings.”

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