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); Unspecified Kidney or Urinary Problem (4503)
Date of Event	02/18/2019
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 february 18, 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.(b)(6).The explanting physician is: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2330 - pain.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 a total vaginal hysterectomy procedure where a solyx sis system was implanted.During the same procedure, anterior colporrhaphy, solyx sling placement, posterior colporrhaphy, right sacrospinous ligament fixation, perineorrhaphy, and cystoscopy were also performed.On (b)(6) 2021, the patient was diagnosed with severe voiding dysfunction and pelvic pain, for which she underwent sling incision and removal.Operative findings revealed the sling located at the mid-urethra, deep to the periurethral fascia.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 dissected circumferentially, cut at the mid-urethra, and removed up to its insertion into the obturator internus muscle bilaterally.The excised sling was sent for pathological analysis.The urethra was inspected and found to be intact.Vaginal packing and a foley catheter were placed postoperatively.The patient tolerated the procedure well and was transferred to recovery 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: 22203757
• Report Number: 2124215-2025-38986
• Device Sequence Number: 15142338
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: (01)08714729774044(17)220107(10)23152171
• 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): 06/13/2025

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: 01/07/2022
• Device Model Number: M0068507000
• Device Catalogue Number: M0068507000
• Device Lot Number: 0023152171
• 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: 06/13/2025
• Date Device Manufactured: 01/08/2019
• 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; Other
• Patient Age: 48 YR
• Patient Sex: Female