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	Pain (1994); Depression (2361); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Unspecified Tissue Injury (4559)
Date of Event	06/01/2020
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 (b)(6) 2020, was chosen as a best estimate based on the date the mesh was implanted.Block d4, h4: the complainant was unable to provide the suspect lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is:(b)(6) regional medical center 1324 lakeland hills blvd, lakeland, fl united states 33805 block h6: the imdrf patient codes capture the reportable events of: e2330 - captures the reported event of pelvic and bladder pain e2015 - captures the reported event of fissures e1405 - captures the reportable event of dyspareunia e1311 - captures the reported event of further or worsening urinary problems e020202 - captures the reported event of depression e0206 - captures the reported event of loss of enjoyment of and mental anguish the imdrf impact code capture the reportable event of: f12 - captures the reportable event of patient had filed a legal claim for personal injury related to the device.
Event or Problem Description
It was reported that the patient who was implanted with this advantage fit system and upsylon y-mesh experienced injuries including: pelvic and bladder pain, fissures, dyspareunia, constipation, further or worsening urinary problems, depression, 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.This manufacturer report pertains to the second of two devices implanted on the same patient.Please refer to mfr report 2124215-2025-12236 for the associated device.
Event or Problem Description
This manufacturer report pertains to the first of two devices implanted on the same patient.Please refer to mfr report 2124215-2025-12236 for the associated device.It was reported that the patient who was implanted with the advantage fit system and upsylon y-mesh underwent robotic-assisted sacrocolpopexy with y-mesh and midurethral sling insertion on (b)(6) 2020, to treat vaginal vault prolapse and stress incontinence.The upsylon y-mesh was anchored to the anterior and posterior vaginal walls and secured to the sacral promontory, while the advantage fit suburethral sling was placed in a tension-free position under the mid-urethra via suprapubic incisions.Cystoscopy confirmed no injury to the bladder or ureters, and the patient was transferred to the postanesthesia care unit in stable condition with no intraoperative complications reported.Following the implantation, the patient reported experiencing injuries including pelvic and bladder pain, fissures, dyspareunia, constipation, further or worsening urinary problems, depression, 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 h2: additional information.Blocks a2 (date of birth), a3a (sex), a3b (gender), b5 (describe event or problem, b7 (other relevant history), and e1 (zip code, initial reporter phone and initial reporter fax) has been updated based on the additional information received.Block b3 date of event: the exact event onset date is unknown.The provided event date of june 1, 2020, was chosen as a best estimate based on the date of the mesh was implanted.Block d4, h4: the complainant was unable to provide the suspect lot number; therefore, the lot expiration and device manufacture dates are unknown.Block d4 unique identifier (udi) #: detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: (b)(6) united states (b)(6).Block h6: the imdrf patient codes capture the reportable events of: e2330 - captures the reported event of pelvic and bladder pain.E2015 - captures the reported event of fissures.E1405 - captures the reportable event of dyspareunia.E1311 - captures the reported event of further or worsening urinary problems.E020202 - captures the reported event of depression.E0206 - captures the reported event of loss of enjoyment of and mental anguish.The imdrf impact code capture the reportable event of: f12 - captures the reportable event of patient had filed a legal claim for personal injury related to the device.

• 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): 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: 21499481
• Report Number: 2124215-2025-12251
• Device Sequence Number: 18073436
• Product Code: OTO
• UDI-Device Identifier: 08714729839217
• UDI-Public: 08714729839217
• 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
• Report Date (Section B): 09/15/2025

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 Model Number: M0068318200
• Device Catalogue Number: 831-820
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 09/15/2025
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Female