Trial Outcomes & Findings for Double-J PLUS Postmarket Registry (NCT NCT04197583)

NCT ID: NCT04197583

Last Updated: 2024-10-16

Results Overview

Technical success was defined as: a stented kidney drains (to bladder) during the planned indwell time with no re-intervention due to obstruction of the stented ureters.

Recruitment status

COMPLETED

Target enrollment

379 participants

Primary outcome timeframe

2 months to 15 Months

Results posted on

2024-10-16

Participant Flow

Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.

This section is not applicable.

Participant milestones

Participant milestones
Measure	Boston Scientific Tria Ureteral Stents Subjects were treated with Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.	Boston Scientific Non- Tria Ureteral Stents Subjects were treated with Non-Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.
Overall Study STARTED	215	164
Overall Study COMPLETED	162	131
Overall Study NOT COMPLETED	53	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Boston Scientific Tria Ureteral Stents Subjects were treated with Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.	Boston Scientific Non- Tria Ureteral Stents Subjects were treated with Non-Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.
Overall Study Study Stent Replacement	34	8
Overall Study Lost to Follow-up	14	3
Overall Study Death	3	0
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	1	1
Overall Study Discontinued. Patient had disseminated metastatic condition	0	1
Overall Study Screen Failure	0	20

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Boston Scientific Ureteral Stents - Tria n=215 Participants Subjects were treated with Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.	Boston Scientific Ureteral Stents - Non-Tria n=144 Participants Subjects were treated with non-Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.	Total n=359 Participants Total of all reporting groups
Age, Continuous	57.2 years n=215 Participants	60.0 years n=144 Participants	58.4 years n=359 Participants
Sex: Female, Male Female	99 Participants n=215 Participants	58 Participants n=144 Participants	157 Participants n=359 Participants
Sex: Female, Male Male	116 Participants n=215 Participants	86 Participants n=144 Participants	202 Participants n=359 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	29 participants n=215 Participants	18 participants n=144 Participants	47 participants n=359 Participants
Region of Enrollment United States	166 participants n=215 Participants	98 participants n=144 Participants	264 participants n=359 Participants
Region of Enrollment Japan	20 participants n=215 Participants	0 participants n=144 Participants	20 participants n=359 Participants
Region of Enrollment France	0 participants n=215 Participants	28 participants n=144 Participants	28 participants n=359 Participants
Quality of Life Endpoint - Patient-Reported Outcomes Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a	44.34 units on a scale n=215 Participants	43.15 units on a scale n=144 Participants	43.86 units on a scale n=359 Participants
Quality of Life Endpoint - Patient-Reported Outcomes Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference 6b	55.09 units on a scale n=215 Participants	53.85 units on a scale n=144 Participants	54.59 units on a scale n=359 Participants

PRIMARY outcome

Timeframe: 2 months to 15 Months

Population: Subjects who provided consent and for whom a Boston Scientific stent placement procedure was initiated were included. Number of units analyzed are stents implanted for more than 12 hours. Results were summarized by Tria and Non-Tria separately. Performance goal was 85% for Tria stone management.

Technical success was defined as: a stented kidney drains (to bladder) during the planned indwell time with no re-intervention due to obstruction of the stented ureters.

Outcome measures

Outcome measures
Measure	Boston Scientific Ureteral Stents - Tria n=246 Stent Implanted Subjects were treated with Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.	Boston Scientific Ureteral Stents - Non-Tria n=160 Stent Implanted Subjects were treated with non-Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.
Percentage of Implanted Stents Meeting the Technical Success Criteria Technical Success Criteria Met	242 Stent Implanted	158 Stent Implanted
Percentage of Implanted Stents Meeting the Technical Success Criteria Technical Success Criteria Not Met	4 Stent Implanted	2 Stent Implanted

PRIMARY outcome

Timeframe: 2 months to 15 Months

Population: Subjects who provided consent and for whom a Boston Scientific stent placement procedure was initiated were included.

Any Serious Adverse Device Effects

Outcome measures

Outcome measures
Measure	Boston Scientific Ureteral Stents - Tria n=215 Participants Subjects were treated with Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.	Boston Scientific Ureteral Stents - Non-Tria n=144 Participants Subjects were treated with non-Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.
Primary Safety Endpoint SADE Experienced	2 Participants	3 Participants
Primary Safety Endpoint No SADEs Experienced	213 Participants	141 Participants

SECONDARY outcome

Timeframe: Change From Index Procedure to Stent Removal Visit; Change From Index Procedure to Post Stent Removal Visit Stent Removal: Typically, within 2 weeks to < 365 days from Index Procedure Post-Stent Removal: Typically, 3 - 12 weeks from Stent Removal

Population: Subjects who provided consent and for whom a Boston Scientific stent placement procedure was initiated were included.

Measurement System Patient Reported Outcomes Measurement Information System (PROMIS®) for subjects ≥18 years * Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity 3a, score range for the change from Index procedure is -41.1 to 41.1 * Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference 6b, score range for the change from Index procedure is -37.3 to 37.3 Higher PROMIS score means worse quality of life

Outcome measures

Outcome measures
Measure	Boston Scientific Ureteral Stents - Tria n=215 Participants Subjects were treated with Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.	Boston Scientific Ureteral Stents - Non-Tria n=144 Participants Subjects were treated with non-Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.
Quality of Life - Patient-Reported Outcomes Pain Intensity Score Change From Index Procedure to Stent Removal Visit	-1.83 score on a scale Interval -37.6 to 31.3	2.04 score on a scale Interval -37.6 to 33.6
Quality of Life - Patient-Reported Outcomes Pain Intensity Score Change From Index Procedure to Post Stent Removal Visit	-9.51 score on a scale Interval -41.1 to 23.4	-10.79 score on a scale Interval -41.1 to 23.0
Quality of Life - Patient-Reported Outcomes Pain Interference Score Change From Index Procedure to Stent Removal Visit	-2.76 score on a scale Interval -37.2 to 37.2	2.25 score on a scale Interval -34.0 to 34.0
Quality of Life - Patient-Reported Outcomes Pain Interference Score Change From Index Procedure to Post Stent Removal Visit	-10.99 score on a scale Interval -37.2 to 24.5	-11.14 score on a scale Interval -37.2 to 22.9

SECONDARY outcome

Timeframe: 2 months to 15 Months

Population: Subjects who provided consent and for whom a Boston Scientific stent placement procedure was initiated were included. Number of units analyzed are for all stents implanted.

Stent Migration: Confirmed via imaging

Outcome measures

Outcome measures
Measure	Boston Scientific Ureteral Stents - Tria n=263 Stent Implanted Subjects were treated with Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.	Boston Scientific Ureteral Stents - Non-Tria n=165 Stent Implanted Subjects were treated with non-Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.
Stent Migration Stent Migration	3 Stent Implanted	2 Stent Implanted
Stent Migration No Stent Migration	260 Stent Implanted	163 Stent Implanted

Adverse Events

Boston Scientific Ureteral Stents - Tria

Serious events: 9 serious events

Other events: 57 other events

Deaths: 3 deaths

Boston Scientific Ureteral Stents - Non-Tria

Serious events: 5 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Director, Clinical Operations

Boston Scientific

Phone: 5133058628

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Boston Scientific Ureteral Stents - Tria n=215 participants at risk Subjects were treated with Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.	Boston Scientific Ureteral Stents - Non-Tria n=144 participants at risk Subjects were treated with non-Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.
Infections and infestations Sepsis	1.4% 3/215 • Number of events 3 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.	0.00% 0/144 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.
Infections and infestations Pneumonia	0.47% 1/215 • Number of events 1 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.	0.00% 0/144 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.
Infections and infestations Pyelonephritis Acute	0.47% 1/215 • Number of events 1 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.	0.00% 0/144 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.
Infections and infestations Urinary Tract Infections	0.00% 0/215 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.	1.4% 2/144 • Number of events 2 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.
Renal and urinary disorders Urinary Retention	0.93% 2/215 • Number of events 2 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.	0.00% 0/144 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.
Cardiac disorders Myocardial Infarction	0.00% 0/215 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.	0.69% 1/144 • Number of events 1 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.
Renal and urinary disorders Urinary Bladder Haemorrhage	0.47% 1/215 • Number of events 1 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.	0.00% 0/144 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.
Cardiac disorders Atrial Fibrillation	0.47% 1/215 • Number of events 1 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.	0.00% 0/144 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.
Cardiac disorders Cardiac Valve Disease	0.47% 1/215 • Number of events 1 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.	0.00% 0/144 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Metastatic	0.47% 1/215 • Number of events 1 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.	0.00% 0/144 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	0.47% 1/215 • Number of events 1 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.	0.00% 0/144 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.
Injury, poisoning and procedural complications Fall	0.47% 1/215 • Number of events 1 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.	0.00% 0/144 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.
Metabolism and nutrition disorders Hypoglycemia	0.47% 1/215 • Number of events 1 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.	0.00% 0/144 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.
Musculoskeletal and connective tissue disorders Flank Pain	0.47% 1/215 • Number of events 1 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.	0.00% 0/144 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.47% 1/215 • Number of events 1 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.	0.00% 0/144 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.
Renal and urinary disorders Renal Pain	0.00% 0/215 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.	0.69% 1/144 • Number of events 1 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.
Infections and infestations Pyelonephritis	0.00% 0/215 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.	0.69% 1/144 • Number of events 1 • up to 11 months. Adverse events were collected from the time of index procedure to end of the study for each subject enrolled. AE reporting includes; all- cause mortality, serious adverse events, and other adverse events (not including serious) SAE includes serious deterioration in health of subject, users or other persons; permanent impairment of a body structure or function including chronic diseases; fetal distress/death or physical or mental impairment.