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

Device Problem Obstruction of Flow (2423)

Patient Problem Discomfort (2330)

Event Date 01/01/2007

Event Type  Injury  

Event Description

Boston scientific corporation became aware of the event through the article, 'external validation of a simplified prognostic model for survival in patients with extrinsic malignant ureteral obstruction treated with tandem ureteral stents a retrospective cohort study'.Reuben ben-davida, yotam veredgorna, ziv savina, yuval bar yosefb, ofer yossepowitcha, mario sofera, and roy manoa.Per the article, the patients who underwent drainage of ureteral obstruction with tandem ureteral stents between january 2007 and january 2020 were reviewed.Patients underwent tandem ureteral stent insertion under general anesthesia.The obstructed segment was assessed with fluoroscopy after injecting contrast media in an ante grade and or retrograde manner.The study cohort consisted of 65 patients (52 females and 13 males) at a median age of 60 years.During the first procedure of tandem stent placement 30 patients required balloon dilatation.Stent failure and nephrostomy tube placement occurred in 8 patients, 6 patients in whom the stents did not drain appropriately, and 2 patients who suffered from severe discomfort due to the presence of the stents.The median time to stent failure was 15 months.Boston scientific has been unable to obtain additional information despite good faith efforts.

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) medical center.Block g2 (literature source): journal article: reuben ben-david, et al, 'external validation of a simplified prognostic model for survival in patients with extrinsic malignant ureteral obstruction treated with tandem ureteral stents a retrospective cohort study'.Scandinavian journal of urology, 2023, vol.57, nos.1 to 6, 90 to 96.Block h6: imdrf device code a1409 captures the reportable event of stent obstructed.Imdrf patient code e2311 captures the reportable event of discomfort.

• Brand Name: PERCUFLEX PLUS 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18735797
• MDR Text Key: 335735904
• Report Number: 2124215-2024-09219
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 02/19/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/19/2024
• 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