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

Model Number M0068507000

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

Patient Problems Erosion (1750); Prolapse (2475); Urinary Incontinence (4572)

Event Date 07/21/2022

Event Type  Injury  

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2022 was chosen as a best estimate based on the date of the revision surgery.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: imdrf patient code e2006 captures the reportable event of sling erosion in the vaginal mucosa.Imdrf impact codes f1905 and f1901 capture the reportable events of partial sling removal and posterior colporrhaphy.

Event Description

It was reported to boston scientific corporation that the patient was diagnosed with cystocele and stress urinary incontinence.On (b)(6) 2018, a solyx sis system was implanted into the patient during an anterior colporrhaphy and pubovaginal sling procedure.There were no patient complications at the conclusion of the procedure.On (b)(6) 2022, the patient was diagnosed with rectocele, stress urinary incontinence and sling erosion in the vaginal mucosa and subsequently underwent a posterior colporrhaphy and a partial pubovaginal sling partial removal procedures on the same day.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17660434
• MDR Text Key: 322368451
• Report Number: 3005099803-2023-04429
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• 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: 08/31/2023

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: 10/30/2020
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0021320633
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female