TRIA? FIRM

Additional Manufacturer Narrative

BLOCK H6: DEVICE CODE A040501 CAPTURES THE REPORTABLE EVENT OF STENT CALCIFIED. PATIENT CODE E2328 CAPTURES THE REPORTABLE EVENT OF URETERAL STONE FORMATION. PATENT CODE E1315 CAPTURES THE REPORTABLE EVENT OF HYDRONEPHROSIS. IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION.

Description of Event or Problem

IT WAS REPORTED THAT A TRIA URETERAL STENT WAS IMPLANTED INTO THE PATIENT'S URETER DURING A FLEXIBLE URETEROSCOPIC LASER LITHOTRIPSY AND URETERAL STENT PLACEMENT UNDER GENERAL ANESTHESIA, PERFORMED ON (B)(6) 2026. POST PROCEDURE, ON (B)(6) 2026, IT WAS FOUND THAT NEW STONES WERE FORMED AGAIN IN THE PATIENT'S URETER. THE IMPLANTED STENT WAS REMOVED, AND ANOTHER FLEXIBLE URETEROSCOPIC LASER LITHOTRIPSY FOR STONE REMOVAL PROCEDURE WAS PERFORMED. THERE WAS NO INFORMATION IF ANOTHER STENT WAS PLACED AND THERE WERE NO OTHER PATIENT COMPLICATION REPORTED.