It was reported to boston scientific corporation that a wallflex esophageal stent was implanted in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on an unknown date.According to the complainant, the stent was implanted to treat a malignant stricture secondary to lung cancer.The physician reported that post-procedure the patient had fever and was coughing out blood.The stent remains implanted.Despite numerous attempts boston scientific has been unable obtain additional information regarding the circumstances surrounding this event.Based on the ambiguity of the reported event, it appears that the patient presented with complications post procedure.It is unknown if/how the fever and hemoptysis may have been treated; however it is possible that the patient received additional medical intervention for this event.Should additional relevant details become available a supplemental report will be submitted.
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The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.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.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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