MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Model Number	M0068507000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Retention (2119); Dyspareunia (4505)
Date of Event	07/03/2019
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 july 3, 2019, was chosen as a best estimate based on the date of mesh implant.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6) the revising physician is: (b)(6) block h6: the following imdrf patient codes capture the reportable events of: e2330 - pain.E1405 - dyspareunia.The following imdrf impact codes capture the reportable events of: f1905 - vaginal mesh removal.
Event or Problem Description
It was reported that the patient underwent an solyx sis system device implant procedure on (b)(6) 2019.During the same surgery, robotic total laparoscopic hysterectomy, bilateral salpingectomy, anterior colporrhaphy, uterosacral plication, and cystoscopy procedures were also performed.On (b)(6) 2020, the patient was diagnosed with severe voiding dysfunction, pelvic pain, and dyspareunia, and underwent mesh removal.During the procedure, sharp dissection was used to separate the vaginal epithelium from the periurethral fascia bilaterally to the level of the inferior pubic ramus.The sling was identified at the mid-urethra, located deep to the periurethral fascia.It was circumferentially dissected, transected at the midline, and removed bilaterally up to its insertion into the obturator internus muscle.The sling was excised and sent for pathological analysis.The urethra was inspected and found to be intact.Copious antibiotic irrigation was performed.Vaginal packing and a foley catheter were placed.The patient tolerated the procedure well and was transferred to the recovery room in stable condition.

• Brand Name: SOLYX SIS SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• 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: 22211453
• Report Number: 2124215-2025-39326
• Device Sequence Number: 8132614
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: (01)08714729774044(17)220505(10)23745563
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K081275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 06/16/2025

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: 05/05/2022
• Device Model Number: M0068507000
• Device Catalogue Number: M0068507000
• Device Lot Number: 0023745563
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/16/2025
• Date Device Manufactured: 05/06/2019
• 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: Other; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female