FDA issues early alert after Boston Scientific AXIOS stent delivery problems linked to injuries and deaths

Device issue affects deployment during endoscopic drainage procedures

Federal regulators have issued an early safety alert involving Boston Scientific’s AXIOS Stent and Electrocautery-Enhanced Delivery System, citing reports of problems during stent deployment and expansion that can force clinicians to prolong procedures or switch devices mid-case.

The alert concerns specific configurations of the AXIOS stent-and-delivery system used in advanced endoscopic procedures to drain certain pancreatic fluid collections and, for some models, to drain the gallbladder in selected high-risk patients who are not suitable candidates for surgery.

What is happening and why it matters

The reported malfunction centers on the delivery phase, when the stent is released and expanded. The underlying concern is difficulty deploying or expanding the stent as intended. When deployment is difficult, physicians may need to exchange the device for a new one, extending procedure time. In cases in which the first flange cannot deploy or expand, additional endoscopic or surgical intervention may be required to remove the stent and close the puncture site.

Regulators have indicated that the issue is expected to occur at the time of delivery and does not affect stents that have already been successfully implanted.

Patients who have already received a successfully implanted AXIOS stent are advised to continue with standard follow-up care, as the identified problem occurs during delivery rather than after implantation.

Scope of the action and reported harm

Boston Scientific has directed affected customers to remove certain AXIOS stent-and-delivery systems from clinical inventory and halt further distribution or use. The company’s customer notice, dated Dec. 19, instructs facilities to segregate remaining affected devices for return and to share the information internally and across any sites or organizations that may have received the products.

As of Dec. 23, Boston Scientific had reported 167 serious injuries and three deaths associated with the deployment-and-expansion issue, based on information reviewed by regulators as part of the ongoing assessment.

What health systems and clinicians are being told to do

• Stop using and distributing affected AXIOS stent-and-delivery systems.
• Remove affected devices from inventory, segregate them, and arrange return procedures.
• Post the notice near relevant storage and procedure areas so handlers and users can readily see it.
• Ensure the notice is shared across departments and any facilities that may have received the devices.

What patients should know

Patients scheduled for endoscopic drainage procedures may wish to ask their care team whether an affected device configuration is used at the facility and what alternatives are available. Patients who have already undergone a procedure involving an AXIOS stent should follow their clinician’s standard post-procedure plan and seek medical attention promptly if new or worsening symptoms occur.

Regulators have said they are continuing to review information and will update public communications as additional findings emerge.