(b)(4).The complainant indicated that the suspect 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 mdr will be filed.
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It was reported to boston scientific corporation on (b)(6) 2018 that an ultraflex tracheobronchial distal release covered stent was implanted to treat a malignant stricture during a stent placement procedure performed on (b)(6) 2018.According to the complainant, during procedure, the stent was deployed inside the patient; however, it was noted that the stent cover was missing.The stent remains 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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