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

Model Number	M0068502000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930); Pain (1994); Urinary Incontinence (4572)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of april 29, 2021, was chosen as a best estimate based on the date of the mesh implant.Block h6: the following imdrf patient code capture the reportable event of: e2006 - erosion.E2330 - pain.The following imdrf impact code capture the reportable event of: f23 - unexpected medical intervention.
Event or Problem Description
It was reported that an advantage system was implanted in the patient on (b)(6) 2021.Sometime after implantation in 2025, clinical examination revealed exposure of the sling on the left vaginal side, associated with severe pain such that minimal manipulation resulted in bilateral retropubic pain radiation.The patient also experienced persistent urinary incontinence.Preoperative endoscopy demonstrated no evidence of urethral or bladder erosion.Given the significant pain and vaginal sling exposure with suspected infection, complete removal of the sling was performed via a laparoscopic approach on (b)(6) 2026.
Additional Manufacturer Narrative
Block h11: correction to blocks d6b (explant date) and h6 (impact codes).Block b3: the exact event onset date is unknown.The provided event date of april 29, 2021, was chosen as a best estimate based on the date of the mesh implant.Block h6: the following imdrf patient code capture the reportable event of: e2006 - erosion.E2330 - pain.The following imdrf impact code capture the reportable event of: f23 - unexpected medical intervention.F1903 - device explantation.
Event or Problem Description
It was reported that an advantage system was implanted in the patient on (b)(6) 2021.Sometime after implantation in 2025, clinical examination revealed exposure of the sling on the left vaginal side, associated with severe pain such that minimal manipulation resulted in bilateral retropubic pain radiation.The patient also experienced persistent urinary incontinence.Preoperative endoscopy demonstrated no evidence of urethral or bladder erosion.Given the significant pain and vaginal sling exposure with suspected infection, complete removal of the sling was performed via a laparoscopic approach on (b)(6) 2026.
Additional Manufacturer Narrative
Block h11: with all the available information, boston scientific concludes that the reported adverse events of erosion, pain, infection, and urinary incontinence are known risks of the surgical procedure.The mesh was returned for analysis; the returned mesh was torn into several pieces.A review of the device history record (dhr) was performed and confirmed that this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Upon receipt at our quality assurance laboratory, the advantage mesh underwent a thorough analysis.Visual inspection revealed a mesh that was torn into several pieces.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.The investigation concluded that the most probable cause for this event is no problem detected since there was no known device problem with the mesh; when the mesh was returned and was observed to be in several pieces from the removal from the patient.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2021, was chosen as a best estimate based on the date of the mesh implant.Block h6: the following imdrf patient code capture the reportable event of: e2006 - erosion, e2330 - pain.The following imdrf impact code capture the reportable event of: f23 - unexpected medical intervention, f1903 - device explantation.
Event or Problem Description
It was reported that an advantage system was implanted in the patient on (b)(6) 2021.Sometime after implantation in 2025, clinical examination revealed exposure of the sling on the left vaginal side, associated with severe pain such that minimal manipulation resulted in bilateral retropubic pain radiation.The patient also experienced persistent urinary incontinence.Preoperative endoscopy demonstrated no evidence of urethral or bladder erosion.Given the significant pain and vaginal sling exposure with suspected infection, complete removal of the sling was performed via a laparoscopic approach on (b)(6) 2026.
Event or Problem Description
It was reported that an advantage system was implanted in the patient on (b)(6), 2021.Sometime after implantation in 2025, clinical examination revealed exposure of the sling on the left vaginal side, associated with severe pain such that minimal manipulation resulted in bilateral retropubic pain radiation.The patient also experienced persistent urinary incontinence.Preoperative endoscopy demonstrated no evidence of urethral or bladder erosion.Given the significant pain and vaginal sling exposure with suspected infection, complete removal of the sling was performed via a laparoscopic approach on (b)(6), 2026.***additional information received on april 23, 2026: information was received that this event is a duplicate.See mfr.Report # 2124215-2025-92789.
Additional Manufacturer Narrative
Correction block b2: outcomes attrib to adv event block b5: describe event or problem.Block h11: with all the available information, boston scientific concludes that the reported adverse events of erosion, pain, infection, and urinary incontinence are known risks of the surgical procedure.The mesh was returned for analysis; the returned mesh was torn into several pieces.A review of the device history record (dhr) was performed and confirmed that this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Upon receipt at our quality assurance laboratory, the advantage mesh underwent a thorough analysis.Visual inspection revealed a mesh that was torn into several pieces.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.The investigation concluded that the most probable cause for this event is no problem detected since there was no known device problem with the mesh; when the mesh was returned and was observed to be in several pieces from the removal from the patient.Block b3: the exact event onset date is unknown.The provided event date of april 29, 2021, was chosen as a best estimate based on the date of the mesh implant.Block h6: the following imdrf patient code capture the reportable event of: e2006 - erosion e2330 - pain.The following imdrf impact code capture the reportable event of: f23 - unexpected medical intervention.F1903 - device explantation.

• Brand Name: ADVANTAGE 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: 24233627
• Report Number: 2124215-2026-05720
• Device Sequence Number: 10188038
• Product Code: OTN
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/15/2026

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: 01/03/2024
• Device Model Number: M0068502000
• Device Catalogue Number: M0068502000
• Device Lot Number: 0026572006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 02/24/2026; 04/10/2026; 04/23/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/17/2026; 04/23/2026; 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2021
• 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