BARD® INLAY OPTIMA® URETERAL STENT

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT HAD PREVIOUSLY UNDERGONE SURGERY FOR URETERAL STONES, AND URETERAL STRICTURE WAS OBSERVED DURING THE OPERATION, SO A URETERAL STENT WAS PLACED. ON (B)(6) 2025, THE PATIENT RETURNED FOR A FOLLOW UP AND HAD A 4.7FR URETERAL STENT BARD REPLACED. THE THEORETICAL LIFESPAN OF THIS TYPE OF URETERAL STENT IS MORE THAN ONE YEAR, AND THE PATIENT WAS ADVISED TO RETURN FOR A FOLLOW UP AFTER SIX MONTHS TO REPLACE OR REMOVE THE URETERAL STENT. ON (B)(6) 2026, THE PATIENT RETURNED TO THE HOSPITAL FOR PLANNED REMOVAL OF THE URETERAL STENT AFTER A SIX-MONTH INTERVAL, BUT THE STENT WAS FOUND TO BE ENTRAPPED AND COULD NOT BE REMOVED. AFTER HOSPITALIZATION, SURGICAL TREATMENT WAS PERFORMED UNDER ANESTHESIA. DURING THE SURGERY, STONES WERE OBSERVED ON THE SURFACE OF THE LEFT URETERAL STENT, AND A THIN SHELL STONE HAD ADHERED TO THE UPPER SEGMENT OF THE LEFT URETERAL STENT. THE STONES WERE CRUSHED WITH LITHOTRIPSY FORCEPS AND THE URETERAL STENT ALONG WITH THE STONES WAS GRADUALLY REMOVED, AND A URETERAL STENT WAS REINSERTED. THE THEORETICAL LIFESPAN OF THIS TYPE OF URETERAL STENT WAS MORE THAN ONE YEAR, BUT IN THIS PATIENT, STONE ADHESION OCCURRED ON THE STENT SURFACE WITHIN SIX MONTHS, CAUSING ENTRAPMENT DURING STENT REMOVAL, INCREASING THE DIFFICULTY OF REMOVAL, RAISING PATIENT COSTS, AND NEGATIVELY AFFECTING THE PATIENT EXPERIENCE.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.