(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure 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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It was reported to boston scientific corporation on (b)(6) 2020 that a wallflex duodenal stent was implanted to treat a 4cm duodenal stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, during the procedure, the stent was deployed.However, it was observed under a video monitor that the stent moved out from the target location.The physician attempted to use a rat tooth forceps to reposition the stent; however, it was unsuccessful.The stent remains implanted and another wallflex duodenal stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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