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

Model Number M0068507010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Erosion (1750); Urinary Incontinence (4572)

Event Date 04/13/2023

Event Type  Injury  

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2023, was chosen as the best estimate based on the revision date.Block h6: imdrf patient code e2101 captures the reportable event of mesh exposure.Imdrf patient code e2006 captures the reportable event of adhesions.Imdrf impact code f19 captures the reportable event of surgical intervention.

Event Description

It was reported to boston scientific corporation that a solyx sis system was used during a mid-urethral sling procedure performed on (b)(6) 2020, for the treatment of stress urinary incontinence.On (b)(6) 2023, the patient underwent an exam under anesthesia and a revision of the mid urethral sling.It was indicated that the patient had developed mesh exposure in the midline urethra that was bothering the patient and her partner.During procedure a cystourethroscopy was performed, revealing no evidence of mesh in the urethra or bladder.The mesh was dissected away from the underlying elements of the pubo-vesico cervical fascia.It was noted that a small portion of mesh that was already incorporated in the tissue was also removed.A second cystourethroscopy was performed, confirming there were no lesions to the bladder.On (b)(6) 2023, the patient presented with recurring stress urinary incontinence leading to a robotic-assisted laparoscopic colpo suspension (burch procedure).During the procedure, adhesions from the omentum to the anterior abdominal wall were noted.The bladder had loss of surgical planes secondary to the adhesions from the previous hysterectomy.Careful lysis of adhesions was performed to release the omentum; however, the adhesions difficulted the process leading to a cystotomy being performed.At the end of the intervention a cystourethroscopy was performed confirming no evidence of masses, lesions, polyps, stones, sutures, or mesh in the bladder.The patient tolerated the procedure well; she was extubated and taken to the recovery room in excellent condition.

• Brand Name: SOLYX SIS SYSTEM
• Type of Device: 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: 19033640
• MDR Text Key: 339261349
• Report Number: 2124215-2024-19105
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729961901
• UDI-Public: 08714729961901
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2023
• Device Model Number: M0068507010
• Device Lot Number: 0026283348
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female