MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP

Model Number	M0068318200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994)
Date of Event	06/06/2023
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 (b)(6) 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 surgeon is: dr.(b)(6).(b)(6).(b)(6).(b)(6).The explanting surgeon is: dr.(b)(6).The assisting surgeons are: dr.S(b)(6).Dr.(b)(6).(b)(6).(b)(6).(b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2330 - captures the reportable event of mesh migration and exposure.E2006 - captures the reportable event of mesh exposure.The following imdrf impact code captures the reportable event of: f1905 - captures the reportable event of exposed mesh removal procedure.Block h11: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.The reported patient symptoms are known risks associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported to boston scientific corporation that an upyslon y-mesh was implanted into the patient during a robotic-assisted laparoscopic sacral colpopexy and labioplasty procedures on (b)(6) 2023, for the treatment of vaginal vault prolapse.The procedure was completed without reported device malfunction or complications, and no mesh exposure was noted at that time.On (b)(6) 2025, the patient presented with vaginal pain and complications related to the implanted device, specifically exposure of the urethral mesh.Intraoperative findings revealed that the anterior arm of the sacrocolpopexy mesh had retracted at the apex, and the exposed mesh was subsequently excised and removed during a robotic-assisted laparoscopic procedure.Following the procedure, the patient's condition was stable, and she was transported to the recovery room having tolerated the procedure well.

• Brand Name: UPSYLON
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway H91 C 2NF; EI H91 C2NF
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25588487
• Report Number: 2124215-2026-26525
• Device Sequence Number: 10286748
• Product Code: OTO
• UDI-Device Identifier: 08714729839217
• UDI-Public: (01)08714729839217(17)260131(10)C004597
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122794
• 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): 05/15/2026

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: 01/31/2026
• Device Model Number: M0068318200
• Device Catalogue Number: 831-820
• Device Lot Number: C004597
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 06/22/2026
• Date Device Manufactured: 01/28/2023
• 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: 41 YR
• Patient Sex: Female