(b)(4).The complainant indicated that the device was disposed 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.
|
It was reported to boston scientific corporation on july 30, 2020 that an ultraflex tracheobronchial covered distal release stent was to be implanted in the trachea during a tracheobronchial stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was deployed from the delivery system; however, the stent failed to expand.The stent was removed from the patient and another ultraflex tracheobronchial stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.
|