NITI-S PYLORIC & DUODENAL UNCOVERED STENT

Additional Manufacturer Narrative

IT WAS REPORTED THAT AFTER 2 MONTHS OF STENT PLACEMENT, THE DISTAL END OF THE STENT WAS FOUND FRACTURED AND ANOTHER STENT WAS PLACED. BASED ON THE ATTACHED PHOTO, IT WAS CONFIRMED THAT THE END OF THE STENT WAS FRACTURED. IT WAS SUCCESSFULLY PASSED IN THE CRITERIA OF MANUFACTURING AND INSPECTION AS A RESULT OF CONFIRMATION OF DEVICE HISTORY RECORD FOR THE RELEVANT PRODUCT. FRACTURE CAN OCCUR BY OTHER COMPANY'S DEVICE AS WELL AS OURS. IT IS AFFECTED BY PATIENT'S LESION STATUS, PERISTALSIS OF ORGANS, AND DRUG USE IN GENERAL. DUODENUM STRUCTURE WHERE STENT WAS IMPLANTED IS CURVY. STENT CAN BE FREQUENTLY PRESSURED DUE TO PATIENT'S LESION STATUS, AND FRACTURE BE POSSIBLE. HOWEVER, IT IS HARD TO IDENTIFY THE EXACT ROOT CAUSE SINCE IT IS HARD TO RECONSTRUCT THE SITUATION AT THE TIME OF PROCEDURE. IT IS HARD TO IDENTIFY THE EXACT ROOT CAUSE SINCE THE DEVICE WAS NOT RETURNED, AND IT IS HARD TO RECONSTRUCT THE SITUATION AT THE TIME OF PROCEDURE. HOWEVER, BASED THE DESCRIPTION "THE DISTAL END OF THE STENT WAS FOUND TO BE FRACTURED" AND END OF THE STENT BEING FRACTURED IN THE ATTACHED PHOTO, IT IS ASSUMED STENT FRACTURE OCCURRED DUE TO THE COMBINATION OF CONTINUOUS STRESS ON THE STENT FROM THE PRESSURE GENERATED FROM THE PATIENT'S LESION AND OTHER FACTORS COMPLEXLY AND ANOTHER STENT WAS PLACED. IN 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: STENT FRACTURE". THIS SUSPECTED DEVICE IS NOT REGISTERED IN THE US BUT WE WILL CONTINUOUSLY MONITOR THE SAME OR SIMILAR CUSTOMER COMPLAINTS THROUGH ACCURATE ANALYSES.

Description of Event or Problem

ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOSCOPIC EXAMINATION, WHICH REVEALED NARROWING OF THE GASTRIC ANTRUM AT THE PYLORUS, PREVENTING PASSAGE OF THE ENDOSCOPE. AFTER SWITCHING TO AN ULTRATHIN ENDOSCOPE, IT WAS BARELY ABLE TO PASS THROUGH TO THE DESCENDING PART. SUBSEQUENTLY, A STENT WAS PLACED WITH THE AID OF A GUIDEWIRE, AND THE STENT WAS IN GOOD POSITION AFTER PLACEMENT. IN (B)(6) 2026, THE PATIENT HAD BEEN EXPERIENCING DISCOMFORT AND THEREFORE RETURNED TO THE HOSPITAL FOR RE-EXAMINATION. THE DISTAL END OF THE STENT WAS FOUND TO BE FRACTURED. THE PATIENT REQUESTED COMPENSATION, AND THE HOSPITAL THEN PLACED ANOTHER STENT. THE ATTACHED IMAGE SHOWS THE FRACTURED STENT EXTENDING INTO THE DESCENDING PART OF THE DUODENUM.