(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation on april 15, 2022 that an agile esophageal otw stent was implanted to treat a 5 cm malignant esophageal stricture in the lower portion of the esophagus during a procedure performed on (b)(6) 2022.During the procedure, the physician was having difficulty seeing the stent under fluoroscopic view but continued with deployment.After the stent was deployed, it was noted to have been placed in an incorrect location.The stent was removed from the patient with forceps and the procedure was completed with a wallflex esophageal stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Note: the physician stated he did not use the rx markers on the delivery system when placing the agile stent, instead he used the constrained stent itself.He is used to the visibility of the wallflex stent under fluoroscopy, so with the agile wires being thinner they were less visible.
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