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	Erosion (1750); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Discomfort (2330); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Urinary Incontinence (4572)
Date of Event	11/23/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a solyx? sis system device implanted during a procedure and has since experienced complications, including vaginal, pelvic and bladder pain, dyspareunia, scarring, mesh erosion/exposure, further or worsening urinary problems 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 november 23, 2016, 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).Block h6: the imdrf patient codes capture the reportable events of: patient code e2330 captures the reportable event of pain including vaginal, pelvic, and bladder pain patient code e1405 captures the reportable event of dyspareunia patient code e2006 captures the reportable event of mesh erosion/exposure patient code e1715 captures the reportable event of scarring patient code e0206 captures the reportable event of physical pain, mental anguish and loss of enjoyment of life.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.
Additional Manufacturer Narrative
Blocks b5 and h11 have been updated based on the additional information received on july 22, 2025.Block b3 date of event: the exact event onset date is unknown.The provided event date of november 23, 2016, 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) hospital block h6: the imdrf patient codes capture the reportable events of: patient code e2330 captures the reportable event of pain including vaginal, pelvic, and bladder pain.Patient code e1405 captures the reportable event of dyspareunia.Patient code e2006 captures the reportable event of mesh erosion/exposure.Patient code e1715 captures the reportable event of scarring.Patient code e0206 captures the reportable event of physical pain, mental anguish and loss of enjoyment of life.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 underwent a surgical procedure involving implantation of the solyx? sis system during a sub urethral sling procedure, which included intraoperative cystoscopy, laparoscopic lysis of adhesions, bilateral salpingo-oophorectomy, and laparoscopic right ureterolysis.Following the implantation, the patient experienced complications, including vaginal, pelvic and bladder pain, dyspareunia, scarring, mesh erosion/exposure, further or worsening urinary problems 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 b2 (outcomes attrib to adv event), (b5 (describe event or problem), b7 (other relevant history), h6 (patient and impact codes) have 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 november 23, 2016, 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).The revised surgery is conducted by: (b)(6).Block h6: the imdrf patient codes capture the reportable events of: patient code e2330 captures the reportable event of pain including vaginal, pelvic, and bladder pain.Patient code e1405 captures the reportable event of dyspareunia.Patient code e2006 captures the reportable event of mesh erosion/exposure.Patient code e1715 captures the reportable event of scarring.Patient code e0206 captures the reportable event of mental anguish and loss of enjoyment of life.Patient code e1311 captures the reportable event of worsening urinary problems.Patient code e1309 captures the reportable event of incomplete bladder emptying.Patient code e2311 captures the reportable event of extreme tenderness at the vaginal apex.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 f1905 captures the reportable event of revision surgery.
Event or Problem Description
It was reported that the patient underwent a sub-urethral sling procedure using the solyx sis system to treat genuine stress urinary incontinence on (b)(6) 2016.Intraoperative cystoscopy revealed normal anatomy with no bladder intrusion.The sling was placed bilaterally into the obturator internus muscles and appropriately tensioned.The sub-urethral incision was closed, and vaginal packing was applied.The patient was transferred to recovery in stable condition, with no complications reported at that time.Following the implantation, the patient experienced several adverse effects, including vaginal, pelvic, and bladder pain; dyspareunia; scarring; mesh erosion or exposure; worsening urinary symptoms; and a diminished quality of life.She also claims to have suffered, or may suffer in the future, damages such as physical pain, mental anguish, physical impairment, and increased medical expenses due to the device.The patient had a history of mid-urethral sling placement in 2006, followed by a repeat procedure in 2016.Since then, she has experienced dyspareunia, which significantly worsened in recent months.On (b)(6) 2023, she presented with complaints of dyspareunia and incomplete bladder emptying.Examination revealed extreme tenderness at the vaginal apex, where scar tissue or suture was palpated, along with a small tender nodule in the upper anterior vagina.The dyspareunia was suspected to be related to the sling or associated scar tissue.A transvaginal ultrasound and surgical intervention were planned.On (b)(6) 2023, the patient underwent revision of the mid-urethral sling and excision of vaginal scar tissue.Under general anesthesia, a mesh exposure or thinly covered mesh area was identified near the urethra.The sling was incised and dissected, and a segment was removed and sent for pathology.Scar tissue from the vaginal apex was also excised.The patient tolerated the procedure well and was transferred to recovery in good 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: 22087612
• Report Number: 2124215-2025-32381
• Device Sequence Number: 15187338
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: (01)08714729774044
• 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: 2016
• 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): 11/05/2025

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: M0068507000
• Device Catalogue Number: M0068507000
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 10/06/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 08/21/2025; 11/05/2025
• 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: Required Intervention; Other
• Patient Age: 45 YR
• Patient Sex: Female