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

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

Patient Problems Erosion (1750); Micturition Urgency (1871); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Obstruction/Occlusion (2422); Prolapse (2475); Dysuria (2684); Constipation (3274); Dyspareunia (4505); Unspecified Tissue Injury (4559); Fecal Incontinence (4571); Insufficient Information (4580)

Event Date 02/23/2023

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2022, revision 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) regional medical center, (b)(6).The physician who performed the revision surgery is: dr.(b)(6), (b)(6) infirmary medical center, (b)(6).The explanting physician is: dr.(b)(6), (b)(6) surgery center, (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2006 - has been used to capture the reported event of mesh showing in the mid/distal six o'clock position.E2328 - has been used to capture the reported event of bladder stones.E2330 - has been used to capture the reported event of back pain.E1715 - has been used to capture the reported event of scarred urethra.E1301 - has been used to capture the reported event of pinching and stabbing pain while voiding.E232401 - has been used to capture the reported event of anal incontinence.E1309 - has been used to capture the reported event of incomplete bladder emptying.E1310 - has been used to capture the reported event of history of urinary tract infection.E1401 - has been used to capture the reported event of a small amount of purulent material.E2015 - has been used to capture the reported event of vaginal atrophy.E2401 - has been used to capture the reported event of presence of intraurethral mesh.The following imdrf impact codes capture the reportable events of: f1905 - has been used to capture the reported event of patient had to undergo device revision.F1903 - has been used to capture the reported event of patient had to undergo excision of sling.F2303 - has been used to capture the reported event of patient is taking mirabegron to address her overactive bladder.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a procedure performed in 2012.The patient underwent a cystoscopy with a laser for bladder stones and removal of a foreign body procedure on (b)(6) 2022.During the procedure, the bladder stones were visualized with the cystoscopy, and the holmium laser was advanced into the bladder alongside the cystoscopy and was used to fragment the stones.The foreign body consistent with mesh was identified and lasered with a holmium laser, and the bulk of the mesh was removed with grasping forceps.Moreover, the patient tolerated the procedure well and was transferred to the post-anesthesia care unit in stable condition.The patient experienced an improvement in their condition following the procedure and was discharged with a catheter in place for several days.Although some pain was associated with the catheter, it subsided after removal.However, the patient still experiences occasional pinching and stabbing pain during urination.On (b)(6) 2022, the patient also reported prolapse symptoms around the stone diagnosis.She has intermittent bulge symptoms and has lost 40 pounds and feels this has helped alleviate her symptoms.She also experiences urinary symptoms, such as leakage when coughing, laughing, sneezing, and leakage with an urge.The patient wears a pad for protection and reports symptoms of urinary urgency and frequency.She voids every hour and experiences nocturia three to four times nightly.The patient also reports feeling like she does not fully empty her bladder.She has attempted to alleviate her symptoms with overactive bladder medications, including mirabegron 50mg for two months.The patient also has a history of urinary tract infections.Additionally, the patient also reports constipation.When she becomes constipated and strains for bowel movements, she describes having an orgasm.She is not taking anything to relieve her constipation.She reports anal incontinence of stool that occurs unexpectedly and without sensation.She complains about vaginal dryness.She denies experiencing vaginal bleeding.She is also not sexually active and complains of pain during intercourse, which prevents her from having sex.The patient also has back pain and bulging discs, she has a pain stimulator, but it is not on, and she plans to remove it.On (b)(6) 2023, the patient reported having mixed urinary incontinence and intravesical mesh.She is taking mirabegron 50 mg tablets that helped her somewhat and allowed her to go out.However, she cannot afford to continue and has no medication for a few days.Moreover, the patient had completed her bladder diary, which was notable of voids ranging from three to fifteen ounces every one to two hours through the day with multiple leaks recorded, including two small, nine medium, and six large leaks, about three-quarters of which were urgency related by her description.A cystoscopy was carried out on (b)(6) 2023, and the patient's bladder mucosa revealed no lesion, stone, or other abnormalities.Bilateral ureteral efflux was observed, as well as normally spaced ureteral orifices.Scarred urethra with white mesh showing in the mid/distal six o'clock position.On (b)(6) 2023, the patient underwent a mesh sling excision urethral reconstruction, excision of permanent suture, and cystourethroscopy.The purpose of this procedure was to rectify the presence of intraurethral mesh, which was identified during the patient's recent cystoscopy and was deemed a persistent issue.During the procedure, it was observed that the mesh terminated at the seven (more distal) and three o'clock (more proximal) positions without any intervening portion.A blue permanent suture was detected beneath the urethra, subsequently removed during dissection.Upon manipulating the sling arms at the urethral exit sites, they discovered some stone encrustation and a small amount of purulent material.The patient presented with mild prolapse and vaginal atrophy.A watertight closure of urethral defects was performed.During the cystourethroscopy, briskly bilaterally effluxing ureters were observed at the end, along with evidence of urethral closure sites.However, no remaining intravesical mesh was located on further bladder inspection.The rest of the bladder inspection was normal.According to the report, the patient tolerated the procedure well and was then moved to the recovery room in stable 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: 17485994
• MDR Text Key: 320657074
• Report Number: 3005099803-2023-04173
• 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: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• 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: 58 YR
• Patient Sex: Female