It was reported to boston scientific corporation on (b)(6) 2022, that an agile esophageal fully covered stent was to be implanted to treat a 2cm benign anastomotic stricture during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was dilated prior to stent placement.During the procedure, the agile stent was being advanced in a "bend" stricture as a result of surgical resection.When the agile stent was attempted to be pulled up 1cm proximally, the stent "jumped" pulling the bottom portion of the agile stent and the agile stent was consequently deployed above the stricture.The agile esophageal stent was removed with standard forceps and the procedure was cancelled due to another of the same device was unavailable.However, this time, the physician is going to use a 10cm agile esophageal stent instead of a 6cm agile esophageal stent due to the location of the stricture.There were no patient complications reported as a result of this event.Note: it was reported that the agile esophageal stent was to be implanted to treat a 2cm benign stricture.Per the instructions for use (ifu), "the agile esophageal fully covered stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic 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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