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

Device Problem Positioning Problem (3009)

Patient Problems Pain (1994); Scar Tissue (2060); Dysuria (2684); Urethral Stenosis/Stricture (4501); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 09/07/2016

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2016, implant date, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6), (b)(6) community hospital (b)(6).The explanting physician is: dr.(b)(6), (b)(6) hospital (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e1311 - has been used to capture the reported event of dysfunctional voiding of urine.E1307 - has been used to capture the reported event of narrowing of urethra.E2330 - has been used to capture the reported event of pelvic and groin pain.E1405 - has been used to capture the reported event of dyspareunia.E2401 - has been used to capture the reported event of intrinsic sphincter deficiency.E1715 - has been used to capture the reported event of scarring.E1301 - has been used to capture the reported event of difficulty voiding.The following imdrf impact codes capture the reportable events of: f1903 - has been used to capture the reported event of sling removal.F2301 - has been used to capture the reported event of patient underwent transurethral bulking injections.F2203 - has been used to capture the reported event of patient underwent a diagnostic cystoscopy.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a pubovaginal sling placement procedure performed on (b)(6) 2016, to treat stress urinary incontinence.After the procedure, a cystoscopy was performed with an unremarkable finding other than urethral stenosis that was dilated in a stepwise fashion to 28 french.The patient was taken to recovery in a stable condition.After the procedure, the patient reported experiencing pain in the pelvic region, pain in the left groin area, dyspareunia, dysfunctional voiding of urine or difficulty voiding, and narrowing of the urethra or scarring.Subsequently, the patient underwent a revision/excision of the suburethral sling, urethrolysis, and diagnostic laparoscopy on (b)(6) 2022.During the initial cystoscopy, the doctor observed some difficulty in passing the cystoscope through the urethra.This led to the question of urethral stricture, which had been previously dilated by another provider during cystoscopy.The movement of the scope and the urethra during the operation caused some tethering of the bladder, which appeared to be caused by the sling on the left side and was in the area where the patient was experiencing pain.Upon the removal of the sling and urethrolysis, it was observed that the sling was located somewhat more cephalad near the bladder neck, and there was dense scarring in the urethral area.The removal of the sling and urethrolysis significantly improved the mobility of the urethrovesical junction.As a result, the scope was able to pass freely through the urethra after the removal of the sling and urethrolysis.A general survey of the bladder showed no evidence of any pathology.There was no indication of urethral injury or cystostomy.No mucosal tethering, visible sutures, or mesh were observed within the bladder walls.Following the administration of indigo carmine intravenously, strong jets of blue dye were observed from both the right and left ureteral ostia.Furthermore, the patient was taken to the recovery room in a stable and well condition.The patient had a procedure on (b)(6) 2022, to address their recurring stress urinary incontinence and intrinsic sphincter deficiency.Transurethral bulking injections and diagnostic cystoscopy were performed, and no signs of pathology, urethral injury, or cystostomy were found during the initial cystoscopy.There were no petechial hemorrhages, ulcerations, or foreign bodies observed.The patient's urethra was approximately 3 cm in length, but poor coaptation was seen along its length.The patient received a total of 2 vials of bulkamid at the 2, 5, 7, and 10 o'clock positions, resulting in excellent coaptation along the entire length of the urethra.The patient was in stable and well condition and was taken to the recovery room.

• 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: 17468956
• MDR Text Key: 320479989
• Report Number: 3005099803-2023-04119
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2023
• 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: 50 YR
• Patient Sex: Female