This report pertains to one of two devices used during the same procedure.Refer to manufacturer report#: 3005099803-2023-05438 for the associated device information.It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was used in the efferent limb to treat a "candy cane syndrome" during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2023.During the procedure, the axios stent (the subject of this report) was deployed; however, the stent's first flange was unable to expand which resulted in the stent moving out of its position.A second axios stent (the subject of mfr.Report#: 3005099803-2023-05438) was used but the same problem occurred.Both stents were removed using rat-tooth forceps.The procedure was completed with a 15mm x 10mm axios stent.There were no patient complications reported as a result of this event.Note: it was reported that the axios stent was to be implanted in the efferent limb to treat a candy cane syndrome.However, per the axios stent and electrocautery-enhanced delivery system instructions for use (ifu), 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 device is not indicated to be placed in the efferent limb for the treatment of candy cane syndrome.
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