Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2024-01084 for the associated device information.It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to the duodenum to treat a gastric outlet obstruction (goo) during an endoscopic ultrasound (eus) with lumen apposing metal stent placement procedure performed on (b)(6) 2024.During the procedure, step 2 of the deployment process was completed; however, the first flange of the stent (the subject of this report) did not expand after being deployed.The physician tried to jiggle the catheter, but the first flange of the stent still did not expand.The stent was removed from the patient partially deployed.Another axios stent (the subject of mfr.Report # 3005099803-2024-01084) was attempted to be used; however, the same issue occurred.The second stent was also removed from the patient partially deployed and the procedure was completed using a third axios stent.There were no patient complications as a result of this event.Note: it was reported that the axios stent was to be implanted to treat a gastric outlet obstruction (goo).However, per the axios stent and electrocautery-enhanced delivery system instructions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6 cm in size and walled-off necrosis >= 6 cm in size that are adherent to the gastric or bowel wall.The axios stent is not indicated to be implanted to treat a gastric outlet obstruction (goo).
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