It was reported that right after the stent placement in esophagus, the patient complained the difficulty in breathing.Observing the bronchus in bronchoscope, the stenosis pushed by stent placement in esophagus was obstructing the bronchus.It was confirmed from the device history record that device had been manufactured with no significant issues and passed all the inspections successfully.It is hard to consider it as the complaint by device malfunction since the stent was normally deployed.However, based on the description "observing the bronchus in bronchoscope, the stenosis pushed by stent placement in esophagus was obstructing the bronchus", it is assumed that after the stent placed in the esophagus, the pushed stenosis was partially obstructing the bronchus, therefore, the patient felts the difficulty in breathing, but it is hard to identify the exact cause since it is hard to reconstruct the situation at the time of procedure and the information such as photo was not provided.Through the user manual by taewoong, it is stated that "potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: airway compressions".This suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.
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Right after the stent placement in esophagus, the patient complained the difficulty in breathing.Observing the bronchus in bronchoscope, the stenosis pushed by stent placement in esophagus was obstructing the bronchus.The stent was removed, and the procedure was finished.There were no patient complications as a result of this event.
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