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); Unspecified Tissue Injury (4559); Insufficient Information (4580)
Date of Event	12/06/2019
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 december 6, 2019, 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 explanting physician is: dr.(b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2330 - captures the reportable event of debilitating pain.E2401 - captures the reportable event of bladder pressure symptoms.E2006 - captures the reportable event of mesh erosion.The following imdrf impact code captures the reportable event of: f1903 - captures the reportable event of removal of mesh.F1202 - captures the reportable event of patient being permanent injured.F12 - captures the reportable event of patient being seriously injured.
Event or Problem Description
It was reported that the patient had an upsylon y-mesh implanted on (b)(6) 2019, during a laparoscopic supracervical hysterectomy, bilateral salpingectomy, robotic sacral colpopexy, posterior repair, cystoscopy, and suture rectopexy for stage ii pelvic organ prolapse.Following surgery, the patient developed complications, including severe pain and recurrent bladder pressure symptoms that worsened over five years.On (b)(6) 2024, diagnostic imaging and cystoscopy revealed mesh erosion into the bladder wall.This required major revision surgery on (b)(6) 2025, involving complete mesh removal, robotic left ureterolysis, and trachelectomy.According to the patient's attorney, the patient has sustained permanent and serious injuries.

• 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: 23724726
• Report Number: 2124215-2025-88820
• Device Sequence Number: 10720433
• Product Code: OTO
• UDI-Device Identifier: 08714729839217
• UDI-Public: (01)08714729839217(17)220630(10)C003941
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K122794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 06/30/2022
• Device Model Number: M0068318200
• Device Catalogue Number: 831-820
• Device Lot Number: C003941
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 05/15/2026
• Date Device Manufactured: 06/17/2019
• 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: 49 YR
• Patient Sex: Female