FDA issues early alert about Boston Scientific’s AXIOS stent, EED system 

Boston Scientific stated that certain AXIOS Stent and Electrocautery Enhanced Delivery Systems have increased reports of issues with stent deployment and expansion. This issue occurs at the time of delivery of the stent and does not affect successfully implanted stents.

Difficulty deploying the stent may prolong the procedure so the device may be exchanged for a new one. In cases where the first flange is unable to deploy or expand, additional endoscopic or surgical intervention may be needed to remove the stent and close the puncture site.

As of December 23, Boston Scientific has reported 167 serious injuries, and three deaths associated with this issue.

Device use
The AXIOS Electrocautery-Enhanced Stent and Delivery System are indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts and/or walled-off necrosis. Certain models may also be used to facilitate drainage of the gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery. U.S. Food and Drug Administration