It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex esophageal partially covered stent was implanted to treat a benign stricture in the esophagus during a stent placement procedure performed on an unknown date.The patient's anatomy was not tortuous.On (b)(6) 2022, during a scheduled stent removal procedure, tissue ingrowth within the wallflex esophageal partially covered stent was noted.During the procedure, the green stent retention suture broke and the wallflex esophageal partially covered stent was unable to be removed.The wallflex esophageal partially covered stent remained implanted and the procedure was rescheduled.On (b)(6) 2022, gastroscopy procedure was performed and a boston scientific fully covered esophageal stent was implanted stent-in-stent to provide pressure necrosis to the tissue ingrowth.On (b)(6) 2022, both partially and fully covered esophageal stents were removed from the patient using a grasping forceps.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 stable.Note: it was reported that the wallflex esophageal partially covered stent was implanted to treat a benign esophageal stricture.Per the ifu, "the wallflex esophageal partially covered stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas".The stent is not indicated for the treatment of benign stricture.
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