Dive Brief:
- Boston Scientific has told customers to stop using certain stents linked to three deaths, the Food and Drug Administration said Friday.
- The FDA published an early alert about issues with deployment and expansion of certain Axios Stent and Electrocautery Enhanced Delivery Systems.
- Boston Scientific wrote to customers about the issues, which the FDA said were linked to 167 serious injuries, late last year to prevent further use of the products.
Dive Insight:
Physicians use the stents to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts or walled-off necrosis. Other uses include gallbladder drainage in people with acute cholecystitis who are at high risk or unsuitable for surgery.
Boston Scientific told customers to stop distributing and using the devices in response to increased reports of stent deployment and expansion issues. The company said the issues only occur during stent delivery, adding that it expects physicians to notice the problem. Successfully implanted stents are not affected by the issue.
Deployment problems may prolong the procedure as the affected device is exchanged for a new one. If the surgeon is unable to deploy or expand the device’s first flange, additional endoscopic or surgical intervention may be needed to remove the stent and close the puncture site.
Boston Scientific said the three deaths were associated with off-label or investigational use of the device. The deaths were linked to the use of Axios in an EDGE procedure and gastrojejunostomy, which are not approved indications, and in an investigational gastroenterostomy clinical trial. A cascade of events with special circumstances, such as a decision for palliative care, limited further treatment options.
Axios is an important product for Boston Scientific. At Boston Scientific’s investor day in September, Brian Dunkin, the company’s chief medical officer, said procedures that were previously performed surgically can be done endoscopically because of Axios. The next month, Boston Scientific CEO Mike Mahoney named Axios among the company’s key products on an earnings call.
The FDA early alert is the second regulatory action targeting Axios in the past 12 months. One year ago, the FDA published a Class 2 recall database entry after Boston Scientific removed certain Axios products from the market. Boston Scientific initiated the recall because of a problem that prevented proper expansion and could delay the completion of procedures.
