IT WAS REPORTED THAT A PATIENT PRESENTED WITH 72% STENOSIS IN THE RIGHT M1 MIDDLE CEREBRAL ARTERY (MCA). THE SUBJECT DEVICE WAS ADVANCED INTO THE STENOSED LESION AND INFLATED TO 6 ATM. THE DEVICE WAS REMOVED AND THE STENOSIS WAS NOT IMPROVED. THE DEVICE WAS READVANCED AND REINFLATED TO 8 ATM. THE STENOSIS SEEMED TO BE IMPROVED UNDER ANGIOGRAPHY AND THE DEVICE WAS REMOVED. HOWEVER, THE CT-SCAN SHOWED A HEMORRHAGE. THE HEMORRHAGE RESULTED IN A STROKE. THE PATIENT WAS TREATED WITH ASPIRIN, LIPITOR AND LIUSUANQINGLUPIGELEI PIAN. ONE DAY POST PROCEDURE THE PATIENT PASSED AWAY.
N
Patient 1
DEVICE WAS DISPOSED.
D
Patient 1
IT WAS REPORTED THAT A PATIENT PRESENTED WITH 72% STENOSIS IN THE RIGHT M1 MIDDLE CEREBRAL ARTERY (MCA). THE SUBJECT DEVICE WAS ADVANCED INTO THE STENOSED LESION AND INFLATED TO 6 ATM. THE DEVICE WAS REMOVED AND THE STENOSIS WAS NOT IMPROVED. THE DEVICE WAS READVANCED AND REINFLATED TO 8 ATM. THE STENOSIS SEEMED TO BE IMPROVED UNDER ANGIOGRAPHY AND THE DEVICE WAS REMOVED. HOWEVER, THE CT-SCAN SHOWED A HEMORRHAGE. THE HEMORRHAGE RESULTED IN A STROKE. THE PATIENT WAS TREATED WITH ASPIRIN, LIPITOR AND LIUSUANQINGLUPIGELEI PIAN. ONE DAY POST PROCEDURE THE PATIENT PASSED AWAY.
N
Patient 1
THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS NOT RETURNED; THEREFORE, ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PATIENT HEMORRHAGE, STROKE AND DEATH ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.