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Patient 1
IT WAS REPORTED THAT, APPROXIMATELY 4 MONTHS AFTER STENT DEPLOYMENT, BY SEEING THE X-RAY, THE STENT WAS FOUND TO BE FRACTURED IN THE PART STICKING OUT. IT WAS CONFIRMED FROM THE DEVICE HISTORY RECORD THAT DEVICE HAD BEEN MANUFACTURED WITH NO SIGNIFICANT ISSUE AND PASSED ALL THE INSPECTIONS SUCCESSFULLY. FRACTURE CAN BE OCCURRED 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, THE STENT WAS NOT RETURNED, AND THE LACK OF INFORMATION SUCH AS THE SUSPECT DEVICE'S PHOTO. BASED ON THE DESCRIPTION, WHICH WAS WRITTEN THAT "DXDT2210 WAS PLACED WITH 2CM OF ITS PROXIMAL SIDE STICKING OUT OF PYLORUS INTO THE STOMACH, AND THE STENT WAS FOUND TO BE FRACTURED IN THE PART STICKING OUT", IT IS ASSUMED THAT THE WIRE WAS SOMEWHAT WEAKENED DUE TO THE PATIENT LESION'S PERISTALSES AND PRESSURE AND FOREIGN SUBSTANCE SUCH AS FOODS, BODY FLUIDS AND SO ON, RESULTED IN STENT FRACTURE. IT IS STATED ON USER MANUAL AS FOLLOWS. POTENTIAL COMPLICATIONS: 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.