MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLARIS (TM) LOOP US W/O SHAFT HOLES; STENT, URETERAL

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

Patient Problems Pain (1994); Sepsis (2067)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Block b3: approximated based on the month and year the first procedures were performed.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 e1: initial reporter facility name: (b)(6) hospital.Block g2 (report source): journal article: jae yong jeong, et al 'impact of preoperative ureteral stenting in retrograde intrarenal surgery for urolithiasis'.Medicicna 2023, 59, 744.Block h6: imdrf patient code e0306 captures the reportable event of sepsis.Imdrf patient code e2330 captures the reportable event of pain.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Mdrf impact codes f2302 captures the reportable event of blood transfusion.

Event Description

Boston scientific corporation became aware of the event through the article, 'impact of preoperative ureteral stenting in retrograde intrarenal surgery for urolithiasis' jae yong jeong, kang su cho, dae young jun, young joon moon, dong hyuk kang, hae do jung, and joo yong lee.Per the article, ureteral stent insertion passively dilates the ureter.Therefore, it is sometimes used preoperatively before flexible ureterorenoscopy to make the ureter more accessible and facilitate urolithiasis passage, especially when ureteroscopic access has failed or when the ureter is expected to be tight.However, it may cause stent-related discomfort and complications.This aimed to assess the effect of ureteral stenting prior to retrograde intrarenal surgery (rirs).The data from patients who underwent unilateral rirs for renal stone with the use of a ureteral access sheath from (b)(6) 2016 to (b)(6) 2019 were retrospectively analyzed.Patient characteristics, including age, sex, bmi, presence of hydronephrosis, and treated side, were recorded.Stone characteristics in terms of maximal stone length, modified seoul national university renal stone complexity score, and stone composition were evaluated.Surgical outcomes, including operative time, complication rate, and stone-free rate, were compared between two groups divided by whether preoperative stenting was performed.There were 260 patients enrolled in this study, 106 patients had no preoperative stenting (stentless group), and 154 patients had stenting (stenting group).Patient characteristics except for the presence of hydronephrosis and stone composition were not statistically different between the two groups.In surgical outcomes, the stone-free rate was not statistically different between the two groups (p = 0.901); however, the operation time for the stenting group was longer than that of the stentless group (44.8 plus minus 24.2 vs.36.1 plus minus 17.6 min; p = 0.001).There were no differences in the complication rate between the two groups (p = 0.523).Two patients in each group experienced postoperative sepsis requiring inotropes, which improved with continued iv antibiotics.Two patients in the stenting group required postoperative blood transfusion.One clavien dindo grade 3a patient who had a postoperative cystoscopic ureteral stent exchange under local anesthesia due to severe pain was in the stentless group.A 6-fr double-j ureteral stent was routinely placed after the retrograde intrarenal surgery (rirs) procedure and maintained for 1 to 2 weeks in all patients.After removal of the postoperative stent on an outpatient basis, follow-up non-contrast a computerized tomography (ct) was performed at 1 to 3 months, and the presence or absence of residual stones confirmed the stone-free status.

• Brand Name: POLARIS (TM) LOOP US W/O SHAFT HOLES
• 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: 18727317
• MDR Text Key: 335715908
• Report Number: 2124215-2024-08766
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• 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
• Date Manufacturer Received: 01/25/2024
• 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