Medical device problem code (b)(4) captures the reportable event of stent migration.Impact code (b)(4) is being used to capture the additional intervention of egd procedure to remove the migrated stent.The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Iit was reported to boston scientific corporation on (b)(6) 2022 that an agile esophageal stent was implanted to treat a 2 cm malignant, tight, pinhole stricture in the mid esophagus due to an esophageal squamous cell carcinoma during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2022.On (b)(6) 2022, post stent placement, during a normal follow-up, the patient presented with dysphasia.Imaging was performed and showed the stent had migrated proximally above the stricture.Another egd procedure was performed, the stent was removed from the patient with rat tooth forceps and another wallflex esophageal stent was implanted to complete the procedure.There was no other intervention or treatment required to address the patient's dysphasia.There were no patient complications reported as a result of this event.
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