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

Model Number M0061802220

Device Problem Difficult to Remove (1528)

Patient Problems Fever (1858); Pain (1994); Urinary Tract Infection (2120); Hematuria (2558); Urethral Stenosis/Stricture (4501); Skin Inflammation/ Irritation (4545)

Event Date 12/01/2023

Event Type  Injury  

Event Description

Boston scientific corporation became aware of the event through the article 'can preoperative ureteral stents reduce the incidence of ureteral stricture after radiotherapy in patients with cervical cancer?', (b)(6).Per the article, the study was a retrospective analysis of data collected from 55 cervical cancer patients treated with radiotherapy between june 2016 and june 2020.The patients in the study were divided into a control group who did not receive stent placement and a group who received ureteral stent placement before radical hysterectomy and the stents were removed at 3 months after radiotherapy.The stricture rate and the complications related to stent placement between the 2 groups were compared.The incidence rates of ureter stricture in the two groups were not significantly different.Complications related to stent placement such as urinary tract infections and bladder irritation were statistically significant between the two groups.The patients in the stent group were treated in the lithotomy position, and the cystoscope was placed under anesthesia.Zebra guidewires were used to place the stents through the renal pelvis.Three months after the end of radiotherapy, 12 patients in the stent group (46.2%) had ureteral stricture, of which 4 were unilateral and 8 were bilateral.There was a total of (b)(4) units and the total incidence of ureteral strictures in the stent group was 38.5%.Ten cases of ureteral stricture occurred in the control group, and the incidence of ureteral stricture was 34.5%.Of them, 5 patients were unilateral, and the remaining patients were bilateral.There was a total of (b)(4) units and the total incidence of ureteral strictures in control was 25.9%.However, there were no significant differences in the incidence rates of ureteral and ureteral strictures between the two groups.Six months after the end of the radiotherapy, 13 patients in the stent group (50.0%) had ureteral stricture, of which 5 were unilateral and 8 were bilateral.There was a total of (b)(4) units and the total incidence of ureteral strictures in the stent group was 40.4%.Ten cases of ureteral stricture occurred in the control group, and the incidence of ureteral stricture was 34.5%.Of them, 5 patients were unilateral and the remaining patients were bilateral.There was a total of (b)(4) units and the total incidence of ureteral strictures in control was 25.9%.However, there were no significant differences in the incidence rates of ureteral stricture and ureteral strictures between the two groups.Complications identified as related to indwelling ureteral stents in the stent group and control were urinary tract infections, lumbar pain, fever, bladder irritation, and hematuria.There were no other complications such as stent displacement and stone formation.Complications were noted at a higher percentage in the indwelling ureteral stent group.The failure to alleviate predominant symptoms or signs, irritative symptoms by ureteral stents, the need for additional therapies, or unexpected or early changing ureteral stents (normal stent placement was 3 months).At 3-month follow-up, 16 patients in the stent group had successfully stent removal (2 patients had a stent replacement due to fever or hydronephrosis after stent removal).Ureteroscopic assessment showed that the ureteral lumen was significantly narrowed in 10 patients, and the stents were successfully replaced.A total of 12 patients failed to remove stents, and the success rate of stent removal was 53.8%.At 6-month follow-up, the 12 patients who were failed to remove stents still had ureteral narrowing, and the stents were continued to be replaced.In the 14 patients who were successfully removed stents, one patient had stent replacement due to ureteral stricture.In the final analysis, preoperative stent placement may not reduce the incidence of ureter stricture in cervical cancer patients treated with adjuvant radiotherapy after radical resection.The success rate of stent removal is low, the stent needs to be replaced regularly, and the complications related to indwelling ureteral stents may occur any time.Thus, preoperative stent placement should be cautious for the clinical management of cervical cancer patients treated with postoperative radiotherapy.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block g2: literature source: liu et al.Bmc urology case report (b)(4).Block h6: imdrf patient code e1302 captures the reportable event of hematuria.Imdrf patient code e1720 captures the reportable event of skin inflammation/irritation.Imdrf patient code e230101 captures the reportable event of fever.Imdrf patient code e1307 captures the reportable event of urethral stenosis/stricture.Imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e1310 captures the reportable event of urinary tract infection.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block g2: literature source: liu et al.Bmc urology case report (2022) 22:106 block h6: imdrf patient code e1302 captures the reportable event of hematuria.Imdrf patient code e1720 captures the reportable event of skin inflammation/irritation.Imdrf patient code e230101 captures the reportable event of fever.Imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e1310 captures the reportable event of urinary tract infection.Block h11: correction to field block h6: patient codes.

Event Description

Boston scientific corporation became aware of the event through the article 'can preoperative ureteral stents reduce the incidence of ureteral stricture after radiotherapy in patients with cervical cancer?', liang liu, chunhong yu, fuzhen sun, tao yang, dong wei, gang wang, shoubin li, and junjiang liu.Per the article, the study was a retrospective analysis of data collected from 55 cervical cancer patients treated with radiotherapy between (b)(6) 2016 and (b)(6) 2020.The patients in the study were divided into a control group who did not receive stent placement and a group who received ureteral stent placement before radical hysterectomy and the stents were removed at 3 months after radiotherapy.The stricture rate and the complications related to stent placement between the 2 groups were compared.The incidence rates of ureter stricture in the two groups were not significantly different.Complications related to stent placement such as urinary tract infections and bladder irritation were statistically significant between the two groups.The patients in the stent group were treated in the lithotomy position, and the cystoscope was placed under anesthesia.Zebra guidewires were used to place the stents through the renal pelvis.Three months after the end of radiotherapy, 12 patients in the stent group (46.2%) had ureteral stricture, of which 4 were unilateral and 8 were bilateral.There was a total of 20 units and the total incidence of ureteral strictures in the stent group was 38.5%.Ten cases of ureteral stricture occurred in the control group, and the incidence of ureteral stricture was 34.5%.Of them, 5 patients were unilateral, and the remaining patients were bilateral.There was a total of 15 units and the total incidence of ureteral strictures in control was 25.9%.However, there were no significant differences in the incidence rates of ureteral and ureteral strictures between the two groups.Six months after the end of the radiotherapy, 13 patients in the stent group (50.0%) had ureteral stricture, of which 5 were unilateral and 8 were bilateral.There was a total of 21 units and the total incidence of ureteral strictures in the stent group was 40.4%.Ten cases of ureteral stricture occurred in the control group, and the incidence of ureteral stricture was 34.5%.Of them, 5 patients were unilateral and the remaining patients were bilateral.There was a total of 15 units and the total incidence of ureteral strictures in control was 25.9%.However, there were no significant differences in the incidence rates of ureteral stricture and ureteral strictures between the two groups.Complications identified as related to indwelling ureteral stents in the stent group and control were urinary tract infections, lumbar pain, fever, bladder irritation, and hematuria.There were no other complications such as stent displacement and stone formation.Complications were noted at a higher percentage in the indwelling ureteral stent group.The failure to alleviate predominant symptoms or signs, irritative symptoms by ureteral stents, the need for additional therapies, or unexpected or early changing ureteral stents (normal stent placement was 3 months).At 3-month follow-up, 16 patients in the stent group had successfully stent removal (2 patients had a stent replacement due to fever or hydronephrosis after stent removal).Ureteroscopic assessment showed that the ureteral lumen was significantly narrowed in 10 patients, and the stents were successfully replaced.A total of 12 patients failed to remove stents, and the success rate of stent removal was 53.8%.At 6-month follow-up, the 12 patients who were failed to remove stents still had ureteral narrowing, and the stents were continued to be replaced.In the 14 patients who were successfully removed stents, one patient had stent replacement due to ureteral stricture.In the final analysis, preoperative stent placement may not reduce the incidence of ureter stricture in cervical cancer patients treated with adjuvant radiotherapy after radical resection.The success rate of stent removal is low, the stent needs to be replaced regularly, and the complications related to indwelling ureteral stents may occur any time.Thus, preoperative stent placement should be cautious for the clinical management of cervical cancer patients treated with postoperative radiotherapy.

• Brand Name: CONTOUR
• Type of Device: 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18509178
• MDR Text Key: 332882147
• Report Number: 2124215-2023-75598
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K974541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

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
• Device Operator: Health Professional
• Device Model Number: M0061802220
• Device Catalogue Number: 180-222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention