Endoscopic Axios Stent and Delivery System Warning From Boston Scientific Follows Multiple Deaths

More than 150 injuries have been reported due to the devices failing to deploy and expand properly.

An investigation is being opened into certain Axios stents and delivery systems used in endoscopic drainage procedures, after multiple injuries and deaths have been linked to deployment or expansion issues with the devices.

The U.S. Food and Drug Administration (FDA) issued a stent and delivery system warning on January 16, noting that the problem occurs during stent placement and does not affect stents that have already been successfully implanted.

Axios Stent and Electrocautery Enhanced Delivery Systems are devices that drain fluid from the pancreas or gallbladder. They are commonly used for pancreatic cysts or areas of dead tissue in the pancreas, and can also be used to drain the gallbladder in patients who are too high-risk for surgery.

The stent is designed to be inserted in a collapsed state and then expand once in place to allow fluid to drain. If the device fails to open properly, drainage can be blocked, increasing the risk of inflammation, infection, pressure buildup that damages surrounding tissue, organ injury or failure, and in severe cases, sepsis.

At least 167 serious injuries and three deaths have been linked to the specific device models named in the FDA warning, leading federal regulators to issue an early alert due to the potential safety risk.

Boston Scientific, the owner of Axios, notified all affected customers of the issue on December 19, recommending they immediately stop distributing or using the affected devices and return them to the company.

The company indicates that the notice should be posted near the affected products and shared with healthcare professionals, organizations that may have received the product and customers.

Patients who have had a successfully implanted Axios stent should continue with standard care, as the issue only occurs during stent placement.

The FDA is currently reviewing information about the device and will update the public as new details become available. Customers with questions can contact Boston Scientific at ComplaintCallCenter@bsci.com.

Health care providers and consumers are encouraged to report any adverse events or product quality concerns related to these devices through MedWatch, the FDA’s safety and adverse event reporting system.

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