URETERAL STENTS
Report
- Report Number
- 1018233-2025-07031
- Event Type
- Malfunction
- Date Received
- August 25, 2025
- Date of Event
- August 13, 2025
- Report Date
- October 8, 2025
- Manufacturer
- C.R. BARD INC. (COVINGTON) -1018233
- Product Code
- FAD
- PMA / PMN Number
- K983498
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION 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.
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS, AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE PRODUCT CATALOG NUMBER AND THE LOT NUMBER FOR THIS DEVICE ARE UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION 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.
IT WAS REPORTED THAT THE URETERAL STENTS PLACED IN PATIENTS' URETERS FREQUENTLY BECOME OBSTRUCTED, PRESENTING A CLINICAL CHALLENGE. CERTAIN URETERAL DOUBLE-J (DJ) STENTS, SUCH AS THE INLAY OPTIMA URETERAL STENT (BD), WERE COATED WITH A SPECIAL COATING TO PREVENT PARTICLE ADHESION BUT WAS PEELING OFF FROM THE STENTS SURFACE. HOWEVER, PROLONGED PLACEMENT IN THE URETER COULD LEAD TO URINARY TRACT INFECTIONS AND POTENTIAL BLOCKAGE OF THE STENT LUMEN BY DEBRIS OR STONES. THE PURPOSE OF THIS STUDY WAS TO CLARIFY THE MECHANISM OF OBSTRUCTION IN URETERAL DJ STENTS PLACED IN PATIENTS. OCCLUDED URETERAL DJ STENTS WERE REMOVED FROM THE PATIENT'S BODY, IMMEDIATELY CUT INTO SMALL PIECES, AND FIXED IN 100% ETHANOL. THE STENT SAMPLES WERE EMBEDDED IN INSULATING RESIN, AND THE CUT AND POLISHED THIN SECTIONS WERE ANALYZED BY SCANNING ELECTRON MICROSCOPY (SEM). THE SAMPLES WERE COATED WITH OSMIUM USING A LOW-TEMPERATURE PLASMA COATING TECHNIQUE DEVELOPED BY US. THIS TECHNIQUE PREVENTS THERMAL DENATURATION OF PROTEINS AND ENABLES PRECISE ANALYSIS OF PATHOLOGICAL SAMPLES. THE STENT LUMEN WAS ANALYZED AT THE ULTRASTRUCTURAL AND ELEMENTAL LEVELS USING CHARACTERISTIC X-RAY ANALYSIS BY SCANNING ELECTRON MICROSCOPE-SEM AND THE ANALYSIS SUGGESTED THAT THE SURFACE OF THE URETERAL STENT WAS CIRCUMFERENTIALLY DELAMINATED AND HAD A LAYER OF CALCIUM PHOSPHATE STONES ATTACHED TO IT. FURTHERMORE, INFECTIOUS STONES, NAMELY MAGNESIUM AMMONIUM PHOSPHATE (MAP) STONES, WERE OBSERVED DEPOSITED ON THE EXTERIOR OF THE DELAMINATED STENT SURFACE. THESE RESULTS SUGGESTED THAT THE DELAMINATION OF THE STENT SURFACE DID NOT OCCUR DURING SAMPLE PREPARATION BUT RATHER OCCURRED NATURALLY ALONG WITH THE LAYER OF CALCIUM PHOSPHATE STONES, FOLLOWED BY DEPOSITION OF THE MAP STONES IN THE PATIENT'S URINARY TRACT. THE RESULTS OF THIS STUDY ARE IMPORTANT FOR ELUCIDATING THE PROCESS OF URETERAL STENT OBSTRUCTION AND SUGGEST THAT DELAMINATION OF THE STENT SURFACE MAY CONTRIBUTE TO OBSTRUCTION. ADDITIONAL VALIDATION USING A LARGER NUMBER OF SAMPLES WAS UNDERWAY TO CONFIRM THIS HYPOTHESIS. AS PER IBC FOLLOW-UP NOTIFICATION RECEIVED ON 20AUG2025, STATED THAT ANALYSIS OF URINARY STONES AND URETERAL STENTS USING SCANNING ELECTRON MICROSCOPY WAS DONE AND CONCLUDED THAT STENT COATINGS CAN FALL OFF OVER TIME INSIDE THE PATIENT'S BODY, POTENTIALLY LEADING TO BLOCKAGES AND REGARDLESS OF THE STONE TYPE, THE DEBRIS WAS PREDOMINANTLY CALCIUM PHOSPHATE, BUT THE NUMBER OF N WAS SMALL. IF CALCIUM PHOSPHATE ACCUMULATES REGARDLESS OF THE TYPE OF STONE, IT CAN BE PREVENTED BY PH CONTROL. STENT COATING THAT WILL NOT FALL OFF NEEDS TO BE DEVELOPED.
IT WAS REPORTED THAT THE URETERAL STENTS PLACED IN PATIENTS' URETERS FREQUENTLY BECOME OBSTRUCTED, PRESENTING A CLINICAL CHALLENGE. CERTAIN URETERAL DOUBLE-J (DJ) STENTS, SUCH AS THE INLAY OPTIMA URETERAL STENT (BD), WERE COATED WITH A SPECIAL COATING TO PREVENT PARTICLE ADHESION BUT WAS PEELING OFF FROM THE STENTS SURFACE. HOWEVER, PROLONGED PLACEMENT IN THE URETER COULD LEAD TO URINARY TRACT INFECTIONS AND POTENTIAL BLOCKAGE OF THE STENT LUMEN BY DEBRIS OR STONES. THE PURPOSE OF THIS STUDY WAS TO CLARIFY THE MECHANISM OF OBSTRUCTION IN URETERAL DJ STENTS PLACED IN PATIENTS. OCCLUDED URETERAL DJ STENTS WERE REMOVED FROM THE PATIENT'S BODY, IMMEDIATELY CUT INTO SMALL PIECES, AND FIXED IN 100% ETHANOL. THE STENT SAMPLES WERE EMBEDDED IN INSULATING RESIN, AND THE CUT AND POLISHED THIN SECTIONS WERE ANALYZED BY SCANNING ELECTRON MICROSCOPY (SEM). THE SAMPLES WERE COATED WITH OSMIUM USING A LOW-TEMPERATURE PLASMA COATING TECHNIQUE DEVELOPED BY US. THIS TECHNIQUE PREVENTS THERMAL DENATURATION OF PROTEINS AND ENABLES PRECISE ANALYSIS OF PATHOLOGICAL SAMPLES. THE STENT LUMEN WAS ANALYZED AT THE ULTRASTRUCTURAL AND ELEMENTAL LEVELS USING CHARACTERISTIC X-RAY ANALYSIS BY SCANNING ELECTRON MICROSCOPE-SEM AND THE ANALYSIS SUGGESTED THAT THE SURFACE OF THE URETERAL STENT WAS CIRCUMFERENTIALLY DELAMINATED AND HAD A LAYER OF CALCIUM PHOSPHATE STONES ATTACHED TO IT. FURTHERMORE, INFECTIOUS STONES, NAMELY MAGNESIUM AMMONIUM PHOSPHATE (MAP) STONES, WERE OBSERVED DEPOSITED ON THE EXTERIOR OF THE DELAMINATED STENT SURFACE. THESE RESULTS SUGGESTED THAT THE DELAMINATION OF THE STENT SURFACE DID NOT OCCUR DURING SAMPLE PREPARATION BUT RATHER OCCURRED NATURALLY ALONG WITH THE LAYER OF CALCIUM PHOSPHATE STONES, FOLLOWED BY DEPOSITION OF THE MAP STONES IN THE PATIENT'S URINARY TRACT. THE RESULTS OF THIS STUDY ARE IMPORTANT FOR ELUCIDATING THE PROCESS OF URETERAL STENT OBSTRUCTION AND SUGGEST THAT DELAMINATION OF THE STENT SURFACE MAY CONTRIBUTE TO OBSTRUCTION. ADDITIONAL VALIDATION USING A LARGER NUMBER OF SAMPLES WAS UNDERWAY TO CONFIRM THIS HYPOTHESIS. AS PER IBC FOLLOW-UP NOTIFICATION RECEIVED ON 20AUG2025, STATED THAT ANALYSIS OF URINARY STONES AND URETERAL STENTS USING SCANNING ELECTRON MICROSCOPY WAS DONE AND CONCLUDED THAT STENT COATINGS CAN FALL OFF OVER TIME INSIDE THE PATIENT'S BODY, POTENTIALLY LEADING TO BLOCKAGES AND REGARDLESS OF THE STONE TYPE, THE DEBRIS WAS PREDOMINANTLY CALCIUM PHOSPHATE, BUT THE NUMBER OF N WAS SMALL. IF CALCIUM PHOSPHATE ACCUMULATES REGARDLESS OF THE TYPE OF STONE, IT CAN BE PREVENTED BY PH CONTROL. STENT COATING THAT WILL NOT FALL OFF NEEDS TO BE DEVELOPED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1578316 | URETERAL STENTS | URETERAL STENTS | FAD | C.R. BARD INC. (COVINGTON) -1018233 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |