It was reported to boston scientific corporation on (b)(6) 2016 that an ultraflex tracheobronchial distal release stent was to be used to dilate a 50 % permanent bronchial block during a stent placement procedure performed on (b)(6) 2016.Reportedly, the patient's anatomy was not tortuous but was dilated prior to stent placement.According to the complainant, during the procedure, the physician was able to fully deploy the stent; however, the distal end of the stent failed to expand.The physician removed the stent using forceps and completed the procedure with another ultraflex tracheobronchial stent.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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