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Patient 1
IT WAS REPORTED THAT, WHEN THE FIRST DEPLOYMENT TRIED, THE STENT WAS NOT EXPANDED, AND WHEN THE SECOND TRIED, THE STENT EXPANSION WAS NOT CONFIRMED THROUGH THE FLUOROSCOPIC IMAGE, RESULTED IN STOP USING, AND THE DELIVERY SYSTEM WAS REMOVED. AS A RESULT OF ANALYSIS OF RETURNED DEVICE, OUTER SHEATH WAS NOT DETACHED, AND THE STENT WAS LOADED. IT WAS OBSERVED THAT THE TIP IS SLIGHTLY INSERTED INTO THE SHEATH. THERE ARE THE FLUENT CURVES ON STENT LOADED PART, AND DEPLOYMENT WAS TRIED WITHOUT PRESSURE, AND IT DEPLOYED WELL. DURING THE DEPLOYMENT, IT WAS OBSERVED THAT THE STENT WAS IMMEDIATELY EXPANDED WELL WITHOUT ANY PROBLEM. IN THE INNER SHEATH, THE NOTABLE KINKED MARK WAS NOT OBSERVED. IT WAS CONFIRMED FROM THE DEVICE HISTORY RECORD THAT DEVICE HAD BEEN MANUFACTURED WITH NO SIGNIFICANT ISSUE AND PASSED ALL THE INSPECTIONS SUCCESSFULLY. AS A RESULT OF ANALYSIS OF RETURNED DEVICE, BASED ON THE DEPLOYMENT WELL UNDER THE NONE PRESSURE, AND THE STENT EXPANSION IMMEDIATELY AFTER DEPLOYMENT, IT IS HARD TO REGARD AS THE DEVICE'S MALFUNCTION. HOWEVER, EVEN THOUGH IT IS HARD TO IDENTIFY THE EXACT ROOT CAUSE SINCE IT IS HARD TO RECREATE THE SITUATION AT THE TIME OF PROCEDURE, BASED ON THE DESCRIPTION, WHICH WAS WRITTEN THAT "CONSIDERING THE DISTAL PART OF THE STENT BEING CAUGHT AT THE STENOSIS, CONTRAST IMAGE WAS TAKEN TO SEE", IT IS CONSIDERED THAT THE STENT WAS DEPLOYED WELL, BUT THE STENT'S DISTAL PART WAS NOT PROPERLY EXPENDED DUE TO PRESSURE BY PATIENT'S LESION, THEREFORE, THE STENT EXPANSION FAIL HAS OCCURRED. IT IS STATED ON USER MANUAL AS FOLLOWS. PROCEDURE: AFTER STENT DEPLOYMENT, BALLOON DILATATION INSIDE THE STENT CAN BE PERFORMED ON DEMAND. PERFORM ROUTINE POST IMPLANT PROCEDURES: A STENT MAY REQUIRE UP TO 1 TO 3 DAYS TO EXPAND FULLY. THIS SUSPECTED DEVICE IS NOT REGISTERED IN THE US BUT WE WILL CONTINUOUSLY MONITOR THE SAME OR SIMILAR CUSTOMER COMPLAINTS THROUGH ACCURATE ANALYSES.