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

Model Number M0068507001

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

Patient Problems Erosion (1750); Micturition Urgency (1871); Urinary Tract Infection (2120); Urinary Frequency (2275); Hematuria (2558)

Event Date 08/10/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: the provided event date of (b)(6) 2016 was chosen as a best estimate based on the information that the symptoms started approximately six months prior to mesh revision surgery on (b)(6) 2017.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Imdrf patient codes e2006, e1302, e1308, e1310 and e1304 capture the reportable events of urethral erosion, urinary tract infection, blood in urine, urinary frequency and urinary urgency.Imdrf impact code f1905 captures the reportable event of mesh excision surgery.

Event Description

Note: this manufacturer report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a cystocele repair with mesh + vaginal vault suspension with mesh + transvaginal tape procedure performed on (b)(6)2009 to treat pelvic organ prolapse and stress urinary incontinence.Postoperatively, approximately six months prior to mesh revision surgery on (b)(6), the patient started having more frequency, urgency, urinary tract infections, and blood in her urine.On cystoscopy she had what looked like urethral erosion of the sling.The patient underwent excision of transvaginal sling + urethroplasty procedure.During the procedure, the right side of the sling was removed all the way towards the entrance into the retropubic space and then cut.The area of erosion was then excised.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16733510
• MDR Text Key: 313228565
• Report Number: 3005099803-2023-01811
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729784784
• UDI-Public: 08714729784784
• 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: 04/13/2023

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: 06/30/2010
• Device Model Number: M0068507001
• Device Catalogue Number: 850-700
• Device Lot Number: 0ML9062306
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female