It was reported that first distal flange did not open completely.And the proximal flare did not open.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Our nitinol wire, the raw material of stent, is shape-memory alloy.Generally, if the stenosis of a patient's lesion is severe, the stent expansion may require some time.However, it is difficult to identify the exact root cause because it is difficult to reconstruct the situation at the time of procedure.It is difficult to identify the exact root cause because the device was not returned, and it is difficult to reconstruct the situation at the time of procedure.However, based on the description "first distal flange did not open completely.And the proximal did not open", it is assumed that the stent expanded somewhat slowly during the procedure due to the condition at the patient's lesion and other factors complexly, so the doctor judged stent expansion failure.Through the user manual by taewoong, it is stated that "a stent may require up to 1 to 3 days to expand fully and balloon dilatation inside the stent can be performed if the physician deems necessary" 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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