Medtronic plc has recalled unused Medtronic Valiant Navion thoracic stent graft system globally, according to the U.S. Food and Drug Administration. The Irish medical technology company also informed physicians to immediately cease use of the device until further notice.
The company initiated the recall following information obtained from the Valiant Evo Global Clinical Trial indicating that three patients in the trial were observed to have stent fractures, two of which have confirmed type IIIb endoleaks. One patient death was reported.
Following these observations, an independent imaging laboratory reviewed all available images from patients enrolled in the Valiant Evo Global Clinical Trial. It was found that seven out of 87 patients were observed to have stent ring enlargement beyond the design specification. Those observations require further assessment to determine potential clinical importance.
Medtronic is currently conducting a comprehensive technical root cause investigation, including further review of follow-up clinical trial imaging and commercial complaints and imaging.
The company has contacted the FDA, along with other regulatory bodies around the world, to share information related to the recall.
Further, Medtronic advises physicians to retrospectively review all available images of patients treated with Valiant Navion thoracic stent graft system with specific attention to stent fractures and type IIIb endoleaks. They are asked to contact the firm if any imaging findings are observed.
Patients with a Medtronic Valiant Navion thoracic stent graft system are urged to consult their physician with any questions.
Source: Read Full Article