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); Hypersensitivity/Allergic reaction (1907); Nerve Damage (1979); Pain (1994); Unspecified Tissue Injury (4559)
Date of Event	02/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a y-mesh and an advantage fit device were implanted on (b)(6), 2017.In 2018, the patient was diagnosed with an autoimmune disease.Subsequent clinical evaluation identified that the mesh eroded into the bladder at two separate sites, migrated through deep pelvic muscles, and embedded in the pubic bone.Due to these findings, the patient underwent complex mesh removal surgeries in (b)(6) 2024 and (b)(6) 2025.At the time of vaginal mesh removal, a native tissue vaginal prolapse repair was also performed.Pathological assessment of bladder tissue associated with mesh erosion identified a precancerous lesion.The patient reported persistent nerve injury and ongoing chronic pain following these interventions.Note: this manufacturer report pertains to the advantage fit device.
Additional Manufacturer Narrative
Block e1: boston scientific received this complaint from a patient via australian regulatory authority (tga).Details related to the initial reporter were not provided.Block h6: the following imdrf patient codes capture the reportable events of: e2006 - mesh erosion e2330 - ongoing pain e0123 - nerve damage e0402 - autoimmune disease e2015 - precancerous lesion the following imdrf patient codes capture the reportable events of: f1905 - patient's mesh removal f1901 - additional surgery of vaginal prolapse repair block h11: the device was not returned for evaluation; therefore, a technical analysis could not be performed.With all available information, bsc concludes that the reported adverse events are known risks of the surgical procedure.Therefore, the investigation concluded that the most probable root cause for this complaint is known inherent risk of device which indicates that the reported adverse event is known and documented in the labeling.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25053335
• Report Number: 2124215-2026-23684
• Device Sequence Number: 15802536
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: (01)08714729772880(17)200424(10)63534
• 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: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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: 04/24/2020
• Device Model Number: M0068502110
• Device Catalogue Number: M0068502110
• Device Lot Number: 0000063534
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/30/2026
• Date Device Manufactured: 04/25/2017
• 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; Other
• Patient Sex: Female