This procedure was performed in (b)(6).The physician was attempting to treat a lesion of 80% stenosis and excessive calcification in a moderately tortuous right ica with a carotid guardwire temporary occlusion embolic protection device.Pre-dilation was carried out at the lesion once at 6atm.There was no anomalous resistance during removal of protective device.No abnormalities were noted during device inspection and preparation before the operation.No resistance was felt when the device was passed through the lesion site.During the operation for cas, the physician considered carrying out distal filter but he confirmed that occipital artery was communicated with the vertebral artery, at the external carotid artery side so it was decided that the guardwire would be used at the external carotid.When the physician attempted to remove the device using an open cell protégé rx stent, after carotid artery stenting (cas) was performed, the guardwire became stuck on the cell and there was a difficulty in removal.The balloon of the guardwire was also ruptured and torn.Then, he stopped using the device.The physician used a new guardwire as replacement to continue the operation.The balloon part adhered to the stent at the external carotid and the carotid stent (cas) procedure was completed.There was no adverse event to the patient, however, the detached piece of the guardwire balloon remains stuck on the protégé.
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