It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted in the pyloric channel and duodenal bulb to treat a benign gastroduodenal stricture during an upper gastrointestinal (gi) endoscopy with a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous.The patient had two previously implanted boston scientific plastic stents which were scheduled for evaluation and removal on (b)(6) 2024.During the routine follow-up procedure, stent ingrowth was noted on the wallflex enteral stent.Consequently, a radiofrequency ablation procedure was performed using a habib device to get rid of the ingrowth.The stent remained implanted, and the procedure was completed.There were no patient complications reported as a result of this event.Note: it was reported that the wallflex enteral stent was implanted to treat a benign gastroduodenal stricture.However, per the wallflex duodenal stent system with anchor lock delivery system instructions for use (ifu), the device is indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.The device is not indicated to be placed for the treatment of benign stricture.
|