FDA flags Bolton thoracic stent graft recall after deaths

The U.S. Food and Drug Administration has issued an early alert about a potentially high-risk issue involving Bolton Medical’s Relay Pro Thoracic Stent Graft System after 3 patient deaths were reported.

The alert covers Relay Pro Thoracic Stent Graft System, N4 non-bare stent configurations 32 mm and above. Bolton Medical sent affected customers an urgent medical device recall correction letter on April 23, and the FDA posted its early alert on April 28.

The device is used in thoracic endovascular aortic repair procedures to reinforce damaged or weakened sections of the thoracic aorta. In the affected devices, the graft may be unable to unclasp from the delivery system because the proximal clasp can be disconnected from the outer control tube, according to the FDA.

The problem may only become apparent during the procedure. FDA said the issue can present as a lack of resistance when the apex holder is slid back, accompanied by failure to release the proximal stent. At that point, the implant cannot be recaptured.

The agency said the failure can cause procedure delays, stent graft displacement, or inability to release the device. In some cases, physicians may need to convert to open surgical repair to release the clasp.

“As of April 23, Bolton Medical has reported three deaths associated with this issue,” the FDA said. Those included 1 aortic perforation and 2 conversions to open surgery that resulted in patient deaths due to stroke.

Bolton Medical’s customer letter recommends that clinicians consider alternative stent graft options before using impacted Relay Pro devices until mitigation measures are in place. The company also instructed customers to review bailout methods in the device instructions for use before procedures.

If release difficulty occurs and no resistance is encountered when sliding the apex holder back, users are advised to attempt existing bailout techniques listed in the instructions for use. If the problem persists, the FDA said there are no additional device bailout methods available, and clinical judgment should guide timely decision-making, including possible conversion to open surgery.

Affected facilities were also told to inform all Relay Pro users of the updated guidance, keep a copy of the recall correction notice with the instructions for use, and post a copy where devices are stored. If devices were transferred to another facility, customers were instructed to share the notification with that site.

The FDA said it is continuing to review information about the issue and will update its early alert page if significant new information becomes available.

For image-guided vascular teams, the alert underscores the importance of device-specific preparation before thoracic endovascular procedures. Because the failure may not be detectable before deployment and has no device-based bailout once it occurs, preprocedural device choice, team awareness, instructions-for-use review, and open surgical contingency planning become central safety considerations.