MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON; MESH, SURGICAL, SYNTHETIC

Model Number	M0068318200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Depression (2361); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505)
Date of Event	12/04/2020
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 4, 2020, 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: (b)(6) united states.Block h6: the imdrf patient codes capture the reportable events of: patient code e2330 captures the reportable event of pain including vaginal, pelvic, perineal and groin pain.Patient code e1002 captures the reportable event of abdominal pain.Patient code e1405 captures the reportable event of dyspareunia.Patient code e1310 captures the reportable event of urinary tract infections.Patient code e020202 captures the reportable event of depression.Patient code e1715 captures the reportable event of severe scarring.Patient code e0206 captures the reportable event of mental anguish.Patient code e1311 captures the reportable event of further or worsening urinary tract problems.The imdrf impact code capture the reportable event of: impact code f12 captures the reportable event of the patient had filed a legal claim for the personal injuries related to the device.
Event or Problem Description
It was reported that the patient had an upsylon y-mesh device implanted during a procedure and has since experienced complications, including vaginal, pelvic, perineal, abdominal and groin pain, dyspareunia, urinary tract infections, further or worsening urinary tract problems, depression, severe scarring and loss of enjoyment of life.Additionally, the patient claims that she has suffered, or may in the future suffer, damages such as physical pain, mental anguish, physical impairment, and medical expenses due to the implantation of the device.
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of december 4, 2020, 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) medical center.Block h6: the imdrf patient codes capture the reportable events of: patient code e2330 captures the reportable event of pain including vaginal, pelvic, perineal and groin pain.Patient code e1002 captures the reportable event of abdominal pain.Patient code e1405 captures the reportable event of dyspareunia.Patient code e1310 captures the reportable event of urinary tract infections.Patient code e020202 captures the reportable event of depression.Patient code e1715 captures the reportable event of severe scarring.Patient code e0206 captures the reportable event of mental anguish.Patient code e1311 captures the reportable event of further or worsening urinary tract problems.The imdrf impact code capture the reportable event of: impact code f12 captures the reportable event of the patient had filed a legal claim for the personal injuries related to the device impact code f1903 captures the reportable event of mesh removal.
Event or Problem Description
It was reported that the patient had an upsylon y-mesh device implanted during a procedure and has since experienced complications, including vaginal, pelvic, perineal, abdominal and groin pain, dyspareunia, urinary tract infections, further or worsening urinary tract problems, depression, severe scarring and loss of enjoyment of life.Additionally, the patient claims that she has suffered, or may in the future suffer, damages such as physical pain, mental anguish, physical impairment, and medical expenses due to the implantation of the device.Additional information received on 21may2025.On (b)(6) 2023, the patient underwent a complex surgical procedure for the removal of da vinci-placed abdominal sacrocolpopexy mesh.The surgery was particularly difficult due to extensive scarring and dense adhesion of the mesh to the right pelvic sidewall and narrow pelvis.Dissection focused on carefully freeing the right mesh arm from the pelvic sidewall and the cul-de-sac-an area of significant difficulty.The remaining mesh attached to the sacrum was dissected and removed.Intraoperative cystoscopy confirmed the integrity of the bladder, showing bilateral ureteral jets.The vaginal canal was lightly packed with iodoform gauze at the conclusion of the procedure.The patient tolerated the surgery well and was transferred to the recovery room in excellent condition.
Event or Problem Description
It was reported that the patient had an upsylon y-mesh device implanted during a procedure and has since experienced complications, including vaginal, pelvic, perineal, abdominal and groin pain, dyspareunia, urinary tract infections, further or worsening urinary tract problems, depression, severe scarring and loss of enjoyment of life.Additionally, the patient claims that she has suffered, or may in the future suffer, damages such as physical pain, mental anguish, physical impairment, and medical expenses due to the implantation of the device.On (b)(6) 2023, the patient underwent a complex surgical procedure for the removal of da vinci-placed abdominal sacrocolpopexy mesh.The surgery was particularly difficult due to extensive scarring and dense adhesion of the mesh to the right pelvic sidewall and narrow pelvis.Dissection focused on carefully freeing the right mesh arm from the pelvic sidewall and the cul-de-sac-an area of significant difficulty.The remaining mesh attached to the sacrum was dissected and removed.Intraoperative cystoscopy confirmed the integrity of the bladder, showing bilateral ureteral jets.The vaginal canal was lightly packed with iodoform gauze at the conclusion of the procedure.The patient tolerated the surgery well and was transferred to the recovery room in excellent condition.
Additional Manufacturer Narrative
Block h11: blocks a2 (age) and b7 have been updated based on the additional information received on october 13, 2025.Block b3 date of event: the exact event onset date is unknown.The provided event date of december 4, 2020, 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) medical center.United states.Block h6: the imdrf patient codes capture the reportable events of: e2330 - pain including vaginal, pelvic, perineal and groin pain, e1002 - abdominal pain, e1405 - dyspareunia, e1310- urinary tract infections, e020202 - depression, e1715 - severe scarring, e0206 - mental anguish, e1311 - further or worsening urinary tract problems.The imdrf impact code capture the reportable event of: f12 captures the reportable event of the patient had filed a legal claim for the personal injuries related to the device.F1903 - mesh removal.

• Brand Name: UPSYLON
• Common Device Name: MESH, SURGICAL, SYNTHETIC
• 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: 21938000
• Report Number: 2124215-2025-26528
• Device Sequence Number: 15413492
• Product Code: OTO
• UDI-Device Identifier: 08714729839217
• UDI-Public: (01)08714729839217(17)230331(10)C004088
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K122794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2025

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: 03/31/2023
• Device Model Number: M0068318200
• Device Catalogue Number: 831-820
• Device Lot Number: C004088
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 05/21/2025; 10/13/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/20/2025; 11/11/2025
• Date Device Manufactured: 03/15/2020
• 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 Age: 33 YR
• Patient Sex: Female