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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Urinary Tract Infection (2120); Hematuria (2558); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

Block b3: the exact date of the event is unknown.The provided event date, 12/01/2023, was chosen as a best estimate based on the date that the manufacturer became aware of the event, 12/20/2023.Blocks 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 (report source): study: boston scientific urology case report pak armed forces med j 2021; 71 (1): 45-50 block e1: initial reporter facility name: (b)(6).Block h6: the following imdrf patient codes capture the reportable event of: e1302 - hematuria e1605 - cramps/muscle spasms e2330 - pain e1310 - urinary tract infection.

Event Description

Boston scientific corporation became aware of the event through the article, '"comparison of solifenacin versus combination of solifenacin and tmasulosin in improving unilateral double-j stent related lower urinary tract symptoms'" muhammad tanveer sajid, sami ur rehman, muhammad akmal, hussain ahmad, zahoor iqbal mirza, arshad mahmood armed forces institute of urology/national university of medical sciences.Per the article, a total of two hundred (n=200) patients who underwent unilateral dj stenting for different endourological procedures, were enrolled after satisfying inclusion/exclusion criteria and then randomly allocated to 2 groups.The patients were carried out under general or regional anesthesia.A soft percuflex stent with hydro plus (contour ureteral stent was used, adjusting the length and caliber for each patient.The patients in the stent group a received solifenacin (5mg) and placebo for two weeks.The patients in stent group b received solifenacin (5mg) tamsulosin (0.4 mg) od for 2 weeks.A plain radiograph of the kidneys, ureters, and bladders confirmed the position of the stents in the patients, prior to discharge.The study indicated complications identified as related to urinary morbidities encountered are voiding / storage symptoms (luts), flank or suprapubic pain, hematuria and urinary tract infection (uti) obviously affecting general health and work performance in as many as 80% cases.Also, spasm of ureteral smooth muscle secondary to foreign body in situ, irritation of trigone by intravesical lower coil leading to bladder spasm and increase retrograde pressure trans-mission during voiding are few such proposed mechanisms augmented by nature of material and size of the stent.Group a and group b were given medications to determine the better treatment for luts in patients with indwelling ureteral stents.The current study revealed significant advantage of combination therapy (solifenacin +- tamsulosin) compared with solifenacin monotherapy in lowering luts (lower urinary tract symptoms) based on ipss (international prostate symptom score) in patients having unilateral dj stent.Additional information is unavailable despite good faith efforts.

Manufacturer Narrative

Block b3: the exact date of the event is unknown.The provided event date, 12/01/2023, was chosen as a best estimate based on the date that the manufacturer became aware of the event, 12/20/2023.Blocks 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 (report source): study: boston scientific urology case report pak armed forces med j 2021; 71 (1): 45-50 block e1: initial reporter facility name: armed forces institute of urology/national university of medical sciences (nums) rawalpindi pakistan.Block h6: the following imdrf patient codes capture the reportable event of: e1302 - hematuria.E1605 - cramps/muscle spasms.E2330 - pain.E1310 - urinary tract infection.Block h11: correction to field block e1: initial reporter address, initial reporter address 2.Initial reporter address city.Initial reporter address country.

Event Description

Boston scientific corporation became aware of the event through the article, '"comparison of solifenacin versus combination of solifenacin and tmasulosin in improving unilateral double-j stent related lower urinary tract symptoms'" muhammad tanveer sajid, sami ur rehman, muhammad akmal, hussain ahmad, zahoor iqbal mirza, arshad mahmood armed forces institute of urology/national university of medical sciences.Per the article, a total of two hundred (n=200) patients who underwent unilateral dj stenting for different endourological procedures, were enrolled after satisfying inclusion/exclusion criteria and then randomly allocated to 2 groups.The patients were carried out under general or regional anesthesia.A soft percuflex stent with hydro plus (contour ureteral stent was used, adjusting the length and caliber for each patient.The patients in the stent group a received solifenacin (5mg) and placebo for two weeks.The patients in stent group b received solifenacin (5mg) tamsulosin (0.4 mg) od for 2 weeks.A plain radiograph of the kidneys, ureters, and bladders confirmed the position of the stents in the patients, prior to discharge.The study indicated complications identified as related to urinary morbidities encountered are voiding / storage symptoms (luts), flank or suprapubic pain, hematuria and urinary tract infection (uti) obviously affecting general health and work performance in as many as 80% cases.Also, spasm of ureteral smooth muscle secondary to foreign body in situ, irritation of trigone by intravesical lower coil leading to bladder spasm and increase retrograde pressure trans-mission during voiding are few such proposed mechanisms augmented by nature of material and size of the stent.Group a and group b were given medications to determine the better treatment for luts in patients with indwelling ureteral stents.The current study revealed significant advantage of combination therapy (solifenacin +- tamsulosin) compared with solifenacin monotherapy in lowering luts (lower urinary tract symptoms) based on ipss (international prostate symptom score) in patients having unilateral dj stent.Additional information is unavailable despite good faith efforts.

• Brand Name: CONTOUR SUREDRIVE
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18508992
• MDR Text Key: 332870301
• Report Number: 2124215-2023-75803
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: PK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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?: No
• Device Operator: Health Professional
• 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: Not provided
• Supplement Dates FDA Received: 05/30/2024
• 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