NITI-S ENTERAL COLONIC UNCOVERED STENT

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE STENT WAS NOT DEPLOYED. THE PHYSICIAN FOUND PERFORATION, AND EMERGENCY SURGERY WAS PERFORMED. IT WAS CONFIRMED FROM THE DEVICE HISTORY RECORD THAT DEVICE HAD BEEN MANUFACTURED WITH NO SIGNIFICANT ISSUE AND PASSED ALL THE INSPECTIONS SUCCESSFULLY. HOWEVER, IT IS HARD TO EXACTLY ANALYZE BECAUSE THE DEVICE WAS NOT RETURNED YET. INVESTIGATION WILL BE CONDUCTED ONCE DEVICE IS RETURNED AND WE WILL SEND FOLLOW-UP REPORT ACCORDINGLY.

Description of Event or Problem

IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED VERY STRONG RESISTANCE AND THE OUTER SHEATH OF THE DELIVERY SYSTEM WAS DETACHED, RESULTED IN DEPLOYMENT FAILURE. THE STENT WAS NOT DEPLOYED AT ALL. THE PHYSICIAN FOUND THAT THERE WAS A PERFORATION ON THE PROXIMAL SIDE OF THE STENOSIS. THE STENT PLACEMENT WAS DISCONTINUED, AND EMERGENCY SURGERY WAS PERFORMED. THE PHYSICIAN SUSPECTS THAT THE PERFORATION OCCURRED DURING THE INSERTION OF THE GUIDEWIRE, NOT DURING THE INSERTION OR REMOVAL OF THE DELIVERY SYSTEM BECAUSE THERE WAS TIGHT CURVE ON THE SCOPE. HOWEVER, IT IS NOT CLEAR WHEN THE PERFORATION OCCURRED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.