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); Urinary Incontinence (4572)

Event Date 01/31/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a solyx sis system device was implanted during a laparoscopy, left oophorectomy, bilateral tubal ligation with bipolar electrocoagulation, hysteroscopy, dilatation, and curettage and solyx sub urethral sling suspension procedure performed on (b)(6) 2015, for the treatment of persistent left adnexal cyst mass, rule out dermoid cyst, desires permanent sterilization, left lower quadrant pelvic pain, menometrorrhagia, dysmenorrhea and stress urinary incontinence with urethral hypermobility.On (b)(6) 2023, the patient underwent placement of pubovaginal sub urethral sling using vnew fascia lata cadaver allograft, revision of mid-urethral sling mesh and cystourethroscopy due to urodynamic stress incontinence and vaginal exposure of mid-urethral sling mesh.The pre-existing mid-urethral sling exposure was approximately 5-8mm in the left lateral vaginal fornix.Tenotomy scissors were used to excise the expected mesh.An area of nodularity due to near mesh exposure in the right lateral vaginal fornix was addressed with a scalpel incision around the approximately 3mm area and tenotomy excision of a small segment of mesh.A series of interrupted and figure of eight 3-0 vicryl sutures were placed to approximate vaginal epithelium.The patient was awakened, extubated, and transferred to post anesthesia care unit in stable condition.

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 e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).Block h6: imdrf patient code e2006 captures the reportable event of vaginal exposure of mid urethral sling mesh.Imdrf impact code f1905 captures the reportable event of revision of mid urethral sling mesh.Imdrf impact code f2301 captures the reportable event of placement of pubovaginal suburethral sling using vnew fascia lata cadaver allograft.

• 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: 17969455
• MDR Text Key: 326122357
• Report Number: 3005099803-2023-05602
• 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: 10/19/2023

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: 05/31/2018
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: ML00002979
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female