FDA Issues Class I Recall for RelayPro Thoracic Stent Graft Following Three Patient Deaths
Deployment failure during aortic repair may require emergency open surgery
The U.S. Food and Drug Administration (FDA) has issued a Class I recall for certain RelayPro Thoracic Stent-Graft Systems manufactured by Bolton Medical, citing a deployment defect that has been associated with three patient deaths.
FDA’s most serious recall classification indicates that continued use of the affected devices may cause serious injury or death.
About the Device
The RelayPro Thoracic Stent-Graft System is used to treat diseases of the thoracic aorta, including thoracic aortic aneurysms, aortic dissections, and traumatic aortic injuries.
The minimally invasive device is intended to reinforce weakened sections of the aorta while maintaining blood flow without requiring open chest surgery.
Affected Devices
The recall affects the RelayPro Thoracic Stent Graft System with an N4 Non-Bare Stent Configuration with a diameter of 32mm and larger.
Healthcare facilities are instructed to immediately discontinue use, isolate affected inventory, and return the devices to the manufacturer.
What Is the Problem?
According to Bolton Medical, the device may fail during deployment because the proximal clasp can become disconnected from the outer control tube, preventing release of the stent graft from the delivery system.
The problem becomes apparent only after deployment has begun. If the malfunction occurs, the stent graft cannot be released properly, the device cannot be recaptured, and no device-based bailout method is available.
Potential consequences include procedure delays, stent graft displacement, failure to deploy the graft, emergency conversion to open surgical repair, and death.
Reported Adverse Events
As of April 23, the manufacturer reported three patient deaths. One death was due to aortic perforation and the other two followed a conversion to open chest surgery complicated by stroke.
Recommended Actions
Healthcare providers should immediately discontinue use of affected RelayPro systems, quarantine affected inventory, notify any facilities that received transferred devices, and return affected products to the manufacturer. Direct any manufacturer communication to Terumo Aortic at Market_Actions-TMC@terumomedical.com.
Links
Read the FDA Announcement here.
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