Fridley, Minn.-based Medtronic’s global recall included informing physicians to immediately cease use of the device until further notice, according to a news release.
The company initiated the recall in response to information it recently obtained from the Valiant Evo global clinical trial which indicated that three patients in the trial experienced stent fractures, with two of which being confirmed type IIIb endoleaks. One patient death was reported.
A Medtronic spokesperson told MassDevice that a secondary reintervention was performed to treat the type IIIb endoleak. Three days after the secondary procedure, the patient experienced hypotension and died. In the absence of an autopsy or explant, the mortality was reported as a probable aortic rupture and adjudicated by the trial’s independent clinical events committee as aneurysm-related mortality because it occurred within 30 days of the secondary procedure.
Upon learning of the observations, an independent imaging laboratory reviewed all available images from the patients enrolled in the trial, finding that seven of 87 patients had stent ring enlargement beyond the design specification. Medtronic said those observations require further assessment to determine potential clinical importance.
The company is conducting a technical root cause investigation, which includes 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,” Medtronic senior VP & president of its structural heart & aortic business Nina Goodheart said in the release. “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.”
This story was updated with additional information surrounding the lone patient death provided by Medtronic.