MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT? SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number	M0068502110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Deformity/ Disfigurement (2360); Obstruction/Occlusion (2422); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Unspecified Tissue Injury (4559); Insufficient Information (4580)
Date of Event	11/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an advantage fit blue system implanted during a procedure and has since experienced complications, including pelvic pain, dyspareunia, vaginal pain, erosion, bladder stones, urinary tract infections, and chronic mesh-related complications.These complications have necessitated multiple surgeries to attempt mesh removal and have resulted in chronic inflammation.Additionally, the patient claims to have suffered the following damages as a result of the implantation: past and future medical and incidental expenses; physical impairment and disfigurement; loss of earnings and diminished earning capacity; impairment of personal relationships; emotional distress; physical pain and suffering; out-of-pocket costs; and other economic and special damages, both past and future.
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2018, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: (b)(6).Block h6: the imdrf patient codes capture the reportable events of: e2330 - captures the reportable event of pelvic and vaginal pain e1405 - captures the reportable event of dyspareunia e2006 - captures the reportable event of erosion e2328 - captures the reportable event of bladder stones e1310 - captures the reportable event of urinary tract infections e2308 - captures the reportable event of disfigurement e0206 - captures the reportable event of emotional distress e2401 - captures the reportable event of physical pain and suffering e2326 - captures the reportable event of chronic inflammation.The imdrf impact code capture the reportable event of: f1901 - captures the reportable event of multiple surgeries.
Additional Manufacturer Narrative
Block h2: additional information: blocks a2 (date of birth), b5 (describe event or problem), and h6 (impact codes) have been updated based on the additional information received.Block b3 date of event: the exact event onset date is unknown.The provided event date of november 5, 2018, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: (b)(6).The explanting physician is: (b)(6).Block h6: the imdrf patient codes capture the reportable events of: e2330 - captures the reportable event of pelvic and vaginal pain.E1405 - captures the reportable event of dyspareunia.E2006 - captures the reportable event of erosion.E2328 - captures the reportable event of bladder stones.E1310 - captures the reportable event of urinary tract infections.E2308 - captures the reportable event of disfigurement.E0206 - captures the reportable event of emotional distress.E2401 - captures the reportable event of physical pain and suffering.E2326 - captures the reportable event of chronic inflammation.The imdrf impact code capture the reportable event of: f1901 - captures the reportable event of multiple surgeries.F1905 - captures the reportable event of vaginal and bladder mesh resection.
Event or Problem Description
It was reported that the patient had an advantage fit blue system implanted during a procedure and has since experienced complications, including pelvic pain, dyspareunia, vaginal pain, erosion, bladder stones, urinary tract infections, and chronic mesh-related complications.These complications have necessitated multiple surgeries to attempt mesh removal and have resulted in chronic inflammation.Additionally, the patient claims to have suffered the following damages as a result of the implantation: past and future medical and incidental expenses; physical impairment and disfigurement; loss of earnings and diminished earning capacity; impairment of personal relationships; emotional distress; physical pain and suffering; out-of-pocket costs; and other economic and special damages, both past and future.On (b)(6) 2024, during cystoscopy for bladder stone removal, eroded bladder suspension mesh was identified and lasered out of the bladder, with residual mesh at the bladder neck treated using a thulium fiber laser.All stone fragments were evacuated, and an 18 french foley catheter was placed; the patient tolerated the procedure well and was transferred to recovery in stable condition without complications.On (b)(6) 2024, cystoscopy revealed a calcified piece of bladder mesh eroding through the right lateral bladder wall, prompting vaginal and bladder mesh resection via an inverted u vaginal incision with dissection into the periurethral tunnel.Both eroded mesh pieces were trimmed from the bladder and bladder neck, and a cystotomy at the resection site was repaired with two layers of interrupted 3-0 vicryl sutures, confirmed watertight by bladder backfill.The vaginal incision was closed with continuous 2-0 vicryl sutures, repeat cystoscopy showed no residual mesh and adequate repair, and a 14 french foley catheter was placed.The patient tolerated the procedure well and was discharged in stable condition without complications.
Additional Manufacturer Narrative
Block h2: additional information: block b5 (describe event or problem) have been updated based on the additional information received.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2018, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: dr.(b)(6).(b)(6) medical center.(b)(6).The explanting physician is: dr.(b)(6).(b)(6) hospital.(b)(6).Block h6: the imdrf patient codes capture the reportable events of: e2330 - captures the reportable event of pelvic and vaginal pain.E1405 - captures the reportable event of dyspareunia.E2006 - captures the reportable event of erosion.E2328 - captures the reportable event of bladder stones.E1310 - captures the reportable event of urinary tract infections.E2308 - captures the reportable event of disfigurement.E0206 - captures the reportable event of emotional distress.E2401 - captures the reportable event of physical pain and suffering.E2326 - captures the reportable event of chronic inflammation.The imdrf impact code capture the reportable event of: f1901 - captures the reportable event of multiple surgeries.F1905 - captures the reportable event of vaginal and bladder mesh resection.
Event or Problem Description
It was reported to boston scientific corporation that an advantage fit blue system was implanted into the patient during a procedure on (b)(6) 2018.After which, she experienced chronic mesh-related complications, including pelvic pain, dyspareunia, vaginal pain, mesh erosion, bladder stones, recurrent urinary tract infections, and chronic inflammation, requiring multiple surgical interventions.The patient alleges ongoing physical and emotional harm and associated economic damages related to the implanted device.On (b)(6) 2024, the patient underwent cystoscopy for bladder stone removal, during which eroded bladder suspension mesh was identified within the bladder and lasered out, with residual mesh at the bladder neck treated using a thulium fiber laser.All stone fragments were evacuated, and an 18 french foley catheter was placed.The patient tolerated the procedure well and was transferred to recovery in stable condition without complications.On (b)(6) 2024, cystoscopy revealed a calcified bladder mesh eroding through the right lateral bladder wall.The patient underwent vaginal and bladder mesh resection, during which eroded mesh from the bladder and bladder neck was trimmed and removed.A cystotomy at the resection site was repaired in two layers and confirmed watertight on repeat cystoscopy, with no residual mesh identified.Pathologic examination of the removed bladder mesh demonstrated fibroconnective and fibromuscular tissue with fibrosis, foreign (suture) material, and mild chronic inflammation, consistent with a foreign body reaction.A foley catheter was placed, the patient remained stable throughout the procedure, and she was discharged the same day in stable condition without complications.On (b)(6) 2024, a follow-up urethrocystoscopy was performed to evaluate prior mesh-related complications.The urethra, bladder neck, trigone, and ureteral orifices were normal, with no evidence of residual mesh, erosion, or device malfunction.The bladder tolerated the procedure without issue, and the patient remained stable during and after the procedure, with no post-procedural complications reported.

• Brand Name: ADVANTAGE FIT? SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22118633
• Report Number: 2124215-2025-31251
• Device Sequence Number: 4251169
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: (01)08714729772880(17)210822(10)22554247
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2021
• Device Model Number: M0068502110
• Device Catalogue Number: M0068502110
• Device Lot Number: 0022554247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 11/04/2025; 02/17/2026
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 12/04/2025; 03/19/2026
• Date Device Manufactured: 08/23/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female