It was reported to boston scientific corporation on (b)(6) 2023 that an agile esophageal otw fully covered stent was implanted in the distal esophagus to treat a laceration during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous.On (b)(6) 2023, two days post stent placement, a computerized tomography (ct) scan was performed and it was observed that the agile esophageal stent had collapsed closed to the lower esophageal sphincter (les).Furthermore, the patient's symptoms of vomiting and nausea prior to the stent placement procedure has not improved.There were no treatments/interventions performed and the agile esophageal stent remained implanted.The patient is currently hospitalized until being transferred out to a new facility.Note: it was reported that the agile esophageal otw stent was implanted to treat a laceration.Per the instructions for use (ifu), "the agile esophageal fully covered otw 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 laceration.It was reported that a 0.035mm bsc guidewire was used.However, per agile esophageal fully covered otw stent system instructions for use, a stiff bodied 0.038 in (0.97mm) guidewire with a floppy tip is recommended to facilitate passage through tortuous anatomy.The user did not use the required guidewire for the procedure.
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