MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRIA FIRM; STENT, URETERAL

Model Number	M0061902230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Urinary Retention (2119)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Study: u0652 double-j registry clinical study.(b)(6).(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
Note: this report pertains to the first of two devices that were used in the same procedure.It was reported to boston scientific corporation that the tria firm ureteral stents were used during stent placement procedure in the left and right ureter for stone management, performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the tria firm ureteral stents were successfully implanted under fluoroscopy in the left and right ureter, and the patient was prescribed the discharge medications of acetaminophen (tylenol) , alpha blocker, anticholinergic, non steroidal anti inflammatory drugs (nsaids), and phenazopyridine.No issues were noted with the devices.During the planned stent removal performed on (b)(6) 2022, the tria ureteral stents were successfully removed from the patient without any difficulty.There were no new device implanted.The patients condition on (b)(6) 2022 experienced bilateral acute pyelonephritis to worsening urinary retention due to anesthesia.The patient was given fentanyl for her pain iv fluids, zosyn and flomax.On (b)(6) 2022 the patient had foley placement.On (b)(6) 2022 the event was considered resolved.In the physicians assessment, the clinical event severe pyelonephritis (unspecified side), reported to be secondary to urinary retention, and reported to be possibly related to the procedure and not related to the stents or removal of the stents, is anticipated in nature and severity.Although worsening urinary retention is not anticipated, the site reported that it was due to anesthesia, not related to the device, and possibly related to the procedure.It was noted that the patient was immunocompromised and was being actively treated for a urinary tract infection.
Additional Manufacturer Narrative
Block g3: study: u0652 double-j registry clinical study.Block e1: initial reporter address 1: (b)(6).Block h6: patient code 9291 captures the reportable event of urinary retention.Patient code 9205 captures the reportable event of pain.Patient code 9151 captures the reportable event of infection.Patient impact code f2303 captures the reportable event of medication required.Patient impact code f08 captures the reportable event of hospitalization.Block h10: block b5 have been updated based on additional information received december 14, 2022.
Event or Problem Description
Note: this report pertains to the first of two devices that were used in the same procedure.It was reported to boston scientific corporation that the tria firm ureteral stents were used during stent placement procedure in the left and right ureter for stone management, performed on (b)(6), 2022 as part of the u0652 double-j registry clinical study.On (b)(6), 2022, the tria firm ureteral stents were successfully implanted under fluoroscopy in the left and right ureter, and the patient was prescribed the discharge medications of acetaminophen (tylenol) , alpha blocker, anticholinergic, non steroidal anti inflammatory drugs (nsaids), and phenazopyridine.No issues were noted with the devices.During the planned stent removal performed on (b)(6), 2022, the tria ureteral stents were successfully removed from the patient without any difficulty.There were no new device implanted.The patients condition on (b)(6), 2022, experienced bilateral acute pyelonephritis to worsening urinary retention due to anesthesia.The patient was given fentanyl for her pain iv fluids, zosyn and flomax.On (b)(6), 2022 the patient had foley placement.On march 30, 2022, the event was considered resolved.In the physicians assessment, the clinical event severe pyelonephritis (unspecified side), reported to be secondary to urinary retention, and reported to be possibly related to the procedure and not related to the stents or removal of the stents, is anticipated in nature and severity.Although worsening urinary retention is not anticipated, the site reported that it was due to anesthesia, not related to the device, and possibly related to the procedure.It was noted that the patient was immunocompromised and was being actively treated for a urinary tract infection.Additional information received that based upon medical review assessment, the data reasonably suggest the clinical event severe bilateral acute pyelonephritis secondary to urinary retention, reported to be possibly related to the procedure and not related to the stents or removal of the stents.Although worsening urinary retention is not anticipated, the site reported that it was due to anesthesia, not related to the device, and possibly related to the procedure.It was noted that the patient was immunocompromised and was being actively treated for a urinary tract infection.Treatment was indicated to be hospitalization, fentanyl, intravenous fluids, zosyn, flomax and foley catheter placement.Additional information received that the patients condition on (b)(6) 2022, experienced bilateral flank pain.On april 15, 2022, the event was considered resolved.
Additional Manufacturer Narrative
Block g3: study: (b)(4) double-j registry clinical study.Block e1: initial reporter address 1: (b)(6).Block h6: patient code 9291 captures the reportable event of urinary retention.Patient code 9205 captures the reportable event of pain.Patient code 9151 captures the reportable event of infection.Patient impact code f2303 captures the reportable event of medication required.Patient impact code f08 captures the reportable event of hospitalization.Block h10: block b5 have been updated based on additional information received february 17.2023.
Event or Problem Description
Note: this report pertains to the first of two devices that were used in the same procedure.It was reported to boston scientific corporation that the tria firm ureteral stents were used during stent placement procedure in the left and right ureter for stone management, performed on (b)(6) 2022, as part of the (b)(4) double-j registry clinical study.On (b)(6) 2022, the tria firm ureteral stents were successfully implanted under fluoroscopy in the left and right ureter, and the patient was prescribed the discharge medications of acetaminophen (tylenol), alpha blocker, anticholinergic, non-steroidal anti-inflammatory drugs (nsaids), and phenazopyridine.No issues were noted with the devices.During the planned stent removal performed on (b)(6) 2022, the tria ureteral stents were successfully removed from the patient without any difficulty.There was no new device implanted.The patient's condition on (b)(6) 2022, experienced bilateral acute pyelonephritis to worsening urinary retention due to anesthesia.The patient was given fentanyl for her pain iv fluids, zosyn and flomax.On (b)(6) 2022, the patient had foley placement.On march 30, 2022, the event was considered resolved.In the physician's assessment, the clinical event severe pyelonephritis (unspecified side), reported to be secondary to urinary retention, and reported to be possibly related to the procedure and not related to the stents or removal of the stents, is anticipated in nature and severity.Although worsening urinary retention is not anticipated, the site reported that it was due to anesthesia, not related to the device, and possibly related to the procedure.It was noted that the patient was immunocompromised and was being actively treated for a urinary tract infection.Additional information received that based upon medical review assessment, the data reasonably suggest the clinical event severe bilateral acute pyelonephritis secondary to urinary retention, reported to be possibly related to the procedure and not related to the stents or removal of the stents.Although worsening urinary retention is not anticipated, the site reported that it was due to anesthesia, not related to the device, and possibly related to the procedure.It was noted that the patient was immunocompromised and was being actively treated for a urinary tract infection.Treatment was indicated to be hospitalization, fentanyl, intravenous fluids, zosyn, flomax and foley catheter placement.Additional information received that the patient's condition on april 14, 2022, experienced bilateral flank pain.On april 15, 2022, the event was considered resolved.Additional information received that the onset date was on march 25, 2022, for the bilateral flank pain.

• Brand Name: TRIA FIRM
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15237650
• Report Number: 3005099803-2022-04437
• Device Sequence Number: 6456319
• Product Code: FAD
• UDI-Device Identifier: 08714729937852
• UDI-Public: 08714729937852
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2024
• Device Model Number: M0061902230
• Device Catalogue Number: 1983-01
• Device Lot Number: 0027751984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2022
• Supplement Date Received by Manufacturer: 12/14/2022; 02/17/2023
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 01/06/2023; 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 71 KG