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

Model Number M0068507000

Device Problem Positioning Problem (3009)

Patient Problems Erosion (1750); Pain (1994); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2016, procedure date, as no event date was reported.The complainant was unable to provide the upn and lot number of the suspect device.The upn provided is a representation of the device implanted during the initial solyx sis system implant procedure.Therefore, the manufacture and expiration dates are unknown.This event was reported by the patient's legal representation.(b)(4).

Event Description

This report pertains to one of two devices implanted into the same patient.Refer to manufacturer report # 3005099803-2022-05841 for the associated device information.It was reported to boston scientific corporation that a solyx sis system was implanted during a tension-free vaginal tape sling implant procedure performed in the past to treat a patient with stress urinary incontinence.The patient experienced persistent stress urinary incontinence and she developed dyspareunia.Evaluation revealed that the patient had a persistent hypermobility of the urethra.A tender sling was felt at the right lateral sulcus of the vagina.Physician's findings includes a proximally placed sling posterior to the bladder neck.On (b)(6) 2016, the patient underwent a sling removal, placement of a new lynx device and cystoscopy procedures.During the procedure, following a successful induction of general anesthesia, the patient was prepped and draped in the usual fashion.An incision was outlined from the bladder neck to just proximal to the urethral meatus.A 20 ml of 0.5% lidocaine with epinephrine in a 1:200,000 concentration were injected in the anterior vaginal wall.The incision was made as outlined.A sharp dissection were used to dissect the periurethral fascia from the vaginal epithelium and from the bladder neck to just proximal to the urethral meatus and lateral to the inferior pubic rami.The sling was noted to be proximal and the physician had to extend his incision proximal to the bladder neck where the physician then located the sling.This was circumferentially dissected off the bladder, cut in the middle and then completely dissected and excised as it inserted into the obturator internus muscle.There, it was cut and sent for pathological analysis.It was quite evident that it was too proximally placed and it explained why the patient persisted with her stress urinary incontinence.The pubocervical and periurethral fascia were then approximated with #3-0 vicryl in an interrupted fashion.The two incisions were then made just off the midline suprapubically.The bladder was drained and then the passers were first passed on the patient's left side from the skin incision to the vaginal incision without difficulties.The same procedure was performed on the right side of the patient.Cystoscopic evaluation revealed no bladder injuries, no urethral injuries and no foreign bodies.The sling was then attached to the passers and brought to the suprapubic incision.Both excess passer and sling were cut and discarded.A right angle was placed between the sling and the urethra.The sleeves were removed and the sling was then secured to the mid urethra at the 12 o'clock position by placing a #4-0 vicryl.The excess sling was cut underneath the skin.The vaginal epithelium was then closed using #2-0 vicryl in a running fashion.A vaginal packing and foley catheter were left in place.The patient tolerated the procedure well and was returned to recovery room in good 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15544925
• MDR Text Key: 301239613
• Report Number: 3005099803-2022-05415
• 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: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female