MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® URETERAL STENT

Catalog Number	788426
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Event or Problem Description
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 reported event was inconclusive because this investigation did not result in any additional findings, and no sample was available for evaluation.Instructions for use were reviewed for this investigation.The reported event is addressed within the labeling as it states.Precautions: ureteral stents should be checked periodically for signs of encrustation and proper function.Periodic checks of the stent by cystoscopic and/or radiographic procedures are recommended at intervals deemed to be appropriate by the physician.In consideration of the individual patient¿s condition and other patient specific factors.When long-term use is indicated, it is recommended that indwelling time not exceed 365 days.Potential complications: potential complications associated with retrograde/antegrade positioning of indwelling ureteral stents include the following: edema ¿ stone formation ¿ peritonitis.Extravasation.Ureteral reflux.Stent dislogdgement.Fistula formation.Loss of renal function fragmentation, migration, occlusion.Hemorrhage.Pain/discomfort ¿ stent encrustation.Hydronephrosis.Perforation of kidney, renal.Ureteral erosion.Infection pelvis, ureter and/or bladder.Urinary symptoms.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.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.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT
• Common Device Name: URETERAL STENT
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 24960243
• Report Number: 1018233-2026-02654
• Device Sequence Number: 18783204
• Product Code: FAD
• UDI-Device Identifier: 00801741015687
• UDI-Public: (01)00801741015687(11)250217(17)290826(10)NGJY0180
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 788426
• Device Lot Number: NGJY0180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown