It was reported to boston scientific corporation that an agile esophageal fully covered stent was implanted in the esophagus to treat a benign stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous.On (b)(6) 2023, during emergent follow-up, the patient presented with bleeding around the distal flange of the stent.The physician believed that the distal flange of the stent eroded the mucosa which resulted in bleeding requiring hospitalization.Subsequently, the stent was removed, and epinephrine was administered to stop the bleeding.Later that day, recurrence of bleeding occurred; however, the patient refused additional care.On the same date, the patient passed away due to blood loss.In the physician's assessment, the relationship between the stent and the patient's death is unknown.Note: it was reported that the agile esophageal stent was implanted to treat a benign stricture.However, per the agile esophageal fully covered stent system instructions for use (ifu), the stent 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 device is not indicated for the treatment of a benign stricture.
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