BARD® INLAY OPTIMA® URETERAL STENT
Received Apr 21, 2026 · Event occurred Apr 8, 2026
Report 1018233-2026-02586 · MDR key 24940106
Device
Generic name
Ureteral Stent
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
788426
Lot number
NGKU3756
Product problems
- Calcified
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT HAD A URETERAL STENT THAT WAS REPLACED PERIODICALLY AFTER RADIATION THERAPY FOR A GYNECOLOGIC TUMOR. THE STENT WAS LAST INSERTED ON (B)(6) 2025, WITH A 4.7FR URETERAL STENT. ON (B)(6) 2026 WHEN THE URETERAL STENT WAS REPLACED, STONES WERE FOUND ADHERING TO THE SURFACE OF THE URETERAL STENT. THE THEORETICAL LIFE SPAN OF THIS TYPE OF URETERAL STENT IS MORE THAN 1 YEAR, BUT WHEN THE PATIENT HAD THE URETERAL STENT REPLACED IN OCTOBER, THERE WERE STONES ADHERING TO THE SURFACE OF THE URETERAL STENT, WHICH MAY LEAD TO DIFFICULTIES IN REMOVING THE STENT FROM THE URETER, AND OTHER ADVERSE EFFECTS.
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.