It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex esophageal fully covered stent was to be used to treat a post surgical anastomotic leak in the esophagus during an esophageal stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed across the anastomotic section.However, the distal flange of the stent was not fully expanded and it appeared that the distal tip of the delivery system was hooked onto the distal end of the stent.During delivery system removal, the stent was pulled proximally out of position.The physician decided to remove the stent with rat tooth forceps and a different stent was placed to complete the procedure.There were no patient complications reported as a result of this event.Note: according to the complainant, the stent was to be used to treat a post surgical anastomotic leak in the esophagus.Per the dfu, "the wallflex 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".
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