Valiant Navion Thoracic Stent Graft System Recall

Sirtex Medical and BlackSwan Vascular Report 1st Patient Enrolled in Pivotal LAVA Study

The LAVA Study, which stands for Liquid Embolization of Arterial Hemorrhages in Peripheral Vasculature, is a prospective, multicenter single-arm study of 113 subjects at 20 investigational sites in the U.S.

Cohen Children’s Medical Center: Covid-19 Teen Returns to Thank the Doctor Who Saved Her Life

It was nothing but bright sunshine at Cohen Children’s Medical Center when Karla Duarte, the first teenager in American to be treated for COVID-19 with extracorporeal membrane oxygenation (ECMO) stopped by to thank the medical team on the one-year anniversary of her discharge.

February 17, 2021

Valiant Navion Thoracic Stent Graft System (unused) recall was announced today by Medtronic. The company has informed physicians to immediately cease use of the device until further notice.

In accordance with its commitment to patient safety, and in consultation with independent physicians, Medtronic initiated this action in response to information recently obtained from the Valiant Evo Global Clinical Trial indicating that three patients in the Valiant Evo Global Clinical 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. Upon further analysis of the images, seven (7) 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.

“There is nothing more important than the safety and well-being of patients,” said Nina Goodheart, senior vice president and president, Structural Heart & Aortic, which is reported as part of the Cardiac Vascular Group at Medtronic. “We treat matters of product safety with the highest priority and urgency. Our decision to implement this voluntary recall is necessary to ensure the utmost patient safety. As our investigation continues, we are committed to timely communication with physicians and regulatory bodies.”

Medtronic has contacted the U.S. Food and Drug Administration (FDA), along with other regulatory bodies around the world, to share information related to this issue. Medtronic will continue working directly with regulatory authorities on this global voluntary recall.

 

spot_img

DON'T MISS

Related Articles