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	Fistula (1862); Urinary Retention (2119); Urinary Incontinence (4572)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of april 4, 2023, 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 and explanting surgeon is: (b)(6).Block h6: the imdrf patient codes capture the reportable events of: e2314 - captures the reportable event of urethrovaginal fistula.E1309 - captures the reportable event of urinary retention.The imdrf impact code capture the reportable event of: f1905 - captures the reportable event of mesh excision.F2301 - captures the reportable event of additional sling device implanted to the patient.
Event or Problem Description
It was reported that the patient had an advantage fit system implanted during a procedure and has since experienced complications including urinary retention resulting in a sling lysis procedure, followed by urethrovaginal fistula and recurrent stress urinary incontinence.Following a mid-urethral sling procedure, the patient experienced postoperative urinary retention for over three weeks.After considering the risks, she chose to undergo sling lysis.Subsequently, approximately one month after advantage fit implantation, she had a cystourethroscopy, partial excision of the mid-urethral sling, and repair of an unavoidable urethrotomy.During the procedure, the sling mesh was identified, elevated, and excised after making a 2 cm incision in the vaginal epithelium.A 1 cm urethrotomy was noted during excision of the midurethral sling.The urethrotomy was closed with multiple layers of 3-0 vicryl sutures, and a vaginal flap was created to ensure watertight closure, confirmed by cystourethroscopy.The patient was stable postoperatively and will have a foley catheter for 2-3 weeks, followed by a voiding cystogram.Approximately 3 months after the sling revision procedure, the patient was seen again and underwent urethrovaginal fistula repair, fascial sling, and cystourethroscopy procedures.The surgical intervention included administering prophylactic antibiotics and general anesthesia, followed by positioning in the dorsal lithotomy position.The surgeon identified the distal urethrovaginal fistula and made a sub-urethral inverted u-incision.An 8 x 1.5 cm fascia graft was excised, prepared, and secured through the space of retzius with prolene sutures.A cystoscopy confirmed no bladder or urethral injuries.The fascial sling was attached at four points under the urethra, and the abdomen was closed with a subcuticular stitch.The vaginal flap was closed with a running stitch, and no vaginal packing was necessary.The patient was transferred to the pacu in stable condition.

• 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: 22018385
• Report Number: 2124215-2025-29256
• Device Sequence Number: 9504806
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: (01)08714729772880(17)251121(10)30583846
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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: 11/21/2025
• Device Model Number: M0068502110
• Device Catalogue Number: M0068502110
• Device Lot Number: 0030583846
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/14/2025
• Date Device Manufactured: 11/22/2022
• 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: 32 YR
• Patient Sex: Female