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

Model Number M0068507000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Micturition Urgency (1871); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Pain (1994); Urinary Retention (2119); Urinary Frequency (2275); Discomfort (2330); Prolapse (2475); Urinary Incontinence (4572)

Event Date 03/25/2013

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a mid urethral sling using solyx and cystoscopy procedure performed on (b)(6) 2013.After the sling placement, the patient complained of pelvic pain as well as pain in her left groin area that started in 2016.She had a hysterectomy in (b)(6) 2016.On (b)(6) 2022, the patient received a suburethral sling revision to address the problem.

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2016 was chosen as a best estimate based on the additional information received indicating the symptoms had started in 2016.Initial reporter name and address: this event was reported by the patient.(b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.

Manufacturer Narrative

Block h2: additional information blocks a2, b5, b7, d6b, h6 has been updated based on the additional information received on september 23, 2022.Correction: blocks b3, e1, e3, h6 (evaluation conclusion codes) has been corrected based on the information received on september 23, 2022.Block b3 date of event: date of event was approximated to (b)(6) 2013, implant procedure date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6) (b)(6) center (b)(6) the mesh revision surgeon is: dr.(b)(6) (b)(6) center united states block h6: patient code e2330, e1309, e2311 capture the reportable events of pain, urinary retention and discomfort.Impact code f1905 captures the reportable event of mesh revision surgery.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a mid urethral sling using solyx and cystoscopy procedure performed on (b)(6) 2013.After the sling placement, the patient complained of pelvic pain as well as pain in her left groin area that started in 2016.She had a hysterectomy in june 2016.On (b)(6) 2022, the patient received a suburethral sling revision to address the problem.Boston scientific received an additional information on 23sep2022 as follows: it was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a hysterectomy, dilatation and curettage, hydrothermal ablation and mid urethral sling placement and cystoscopy procedure performed on (b)(6) 2013, for the treatment of menorrhagia, failing medical management and stress urinary incontinence.On (b)(6) 2021, the patient underwent a consultation at a clinic with the chief complaint of pain in her left groin.In the course of the patient's examination by a doctor in the said area, it was discovered that she had significant left groin pain.Since 2016, the patient claimed she had intermittent left-sided groin pain.She characterized it as being intense, sharp, occasionally tight, and severe enough to make activity difficult.The patient thought her sciatic nerve was causing behind her pain.Moreover, a vaginal exam was performed and found there was no extrusion noted, but there was a left peri-urethral tenderness to palpation at the left obturator internus sling insertion point.After her assessment in september, she claimed that her pain was consistent and that the sling had only provided temporary relief.She also claimed that she experienced pain twice a week.On october 5, 2021, she also had a pelvic ultrasound, which revealed a 1.5 x 2.6 x 1.2 cm stable left ovarian cyst.Her doctor advised her to return in 6 to 8 months for a follow-up image.Furthermore, the patient was found to have mixed urinary incontinence, pelvic pain, rectocele, and incomplete bladder emptying during the consultation.On (b)(6) 2022, the patient returns in the clinic with continued complaints of urinary incontinence, urinary urgency and pelvic pain.Prior to the patient's consultation, she underwent urodynamics procedure on (b)(6)2022, and (b)(6) 2022, and the findings are as follows: urodynamic date: (b)(6) 2022 * uroflowmetry with 15 ml uniphasic and postvoid residuals * stress urinary incontinence was noted without prolapse reduction at 150 ml.The valsalva leak point pressure was 46 cm h20.* mean urethral closure pressures were normal (93 cm h20) without prolapse reduction.There was no evidence of intrinsic sphincter deficiency.* detrusor instability at 151 ml.Urodynamic b date: (b)(6) 2022 * bladder sensation was normal (220 ml), and bladder capacity was decreased (341 ml).* stress urinary incontinence was not noted.* detrusor instability was not noted at 341 ml.* the voiding mechanism was normal.The postvoid residual was 150 ml.A cystoscopy of the bladder was also conducted using a 70-degree panendoscope, that revealed trabeculation.It was also observed that straining or coughing resulted in +1 transillumination of the bladder.A genitourinary examination was also performed, which revealed +1 periurethral tenderness to palpation at the location where the sling was inserted.She also has urgency and urgency leakage.An elevated post-void residue was also observed.The doctor had discussed about sling revision and the implantation of a new suburethral sling.The doctor also thoroughly discussed the patient's urodynamics testing and cystoscopy findings.There was urethral tenderness, a decreased bladder capacity (350 ml), and stress incontinence.They also went through all of the therapy options, including pessary or surgical correction.The patient wishes surgical correction in the form of a sling revision and suburethral sling with tension-free vaginal tape.It has also been thoroughly discussed the risks of the surgery, which include organ damage, infection, and bleeding.The patient was counseled on preoperative and postoperative preparation.To address recurrent mixed urinary incontinence and pelvic pain, the patient underwent a revision of the suburethral sling, placement of a retropubic suburethral sling, and cystoscopy on (b)(6) 2022.During the surgery, the patient was carefully prepped and draped in a standard method so that there was no excessive knee bending or lateral leg compression in the low or high lithotomy position.The lone start retractor was used for visualization once everything had been properly prepped and draped.The urethral area was assessed.The previous operation site was injected with a lidocaine, marcaine, and epinephrine solution.A 15-blade scalpel was used to make an incision in the mucosa near the kidney, about 1 cm proximal to the urethral meatus.The mucosal margins were gripped with an allis clamp at this point, and periurethral dissection was performed on the right side with metzenbaum scissors.For visualization, the lone star retractor was used.The dissection was then handled carefully.The finding of the sling mesh was difficult.Sharp dissection revealed an area of indentation all the way to the distal area, consistent with a possible mesh sling.The sling was identified after area was carefully dissected free with sharp dissection.It was separated from the urethra after being undermined.A kocher clamp was used to secure the edges.It was then cut in the middle and separated into two arms on each side, right and left.As much as possible, dissection was performed laterally, and the sling was trimmed in each area.The prior sling bed was reconstructed with 3-0 vicryl interrupted sutures at this point, bringing the edges of the endopelvic fascia together and closing off this area.Interrupted 2-0 vicryl sutures were also used for hemostasis as needed.After that, the suprapubic area was marked with a ruler and noted in the midsagittal plane, allowing the sagittal plane to be 2 cm away from the midsagittal plane.The retzius space was hydrodissected using a 20-gauge spinal needle and a 30-cc syringe filled with 0.5% lidocaine and epinephrine solution.The focus then shifted to the dissection site.The catheter guide deviated the urethra to the patient's left, while the tvt trocar was implanted in the right periurethral dissection plane.The trocar device was gently advanced behind the pubic bone, aiming for the patient's ipsilateral shoulder.It was important to hug the pubic bone, go around it, not deviate laterally, and come out in 2 cm of midsagittal plane.A 70-degree scape cystoscopy showed no bladder or urethral damage.These maneuvers were repeated in a similar fashion on the opposite side.A repeat cystoscopy revealed no bladder or urethral damage.Mayo scissors were used to elevate the tape sheets and separate them from the urethra.Each tape sheet was removed separately.The application was tension-free.A 5cc floseai was put in each periurethral dissecting area to ensure hemostasis.The wound was subsequently closed with a 2-0 vicryl running lock suture.Dissection was associated with two periurethral windows.These were closed with interrupted 2-0 vicryl sutures.Hemostasis was appreciated.The procedure was well tolerated by the patient, who was brought to the recovery room in stable condition with a foley catheter in place.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to march 25, 2013, implant procedure date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6); (b)(6) center.The mesh revision surgeon is: dr.(b)(6); (b)(6) center.Block h6: patient code e2330, e1309, e2311, e2320, e2326, e0506 capture the reportable events of pain, urinary retention, discomfort, urinary retention, hypertension, inflammation and hemorrhage.Impact code f1905 captures the reportable event of mesh revision surgery.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a mid urethral sling using solyx and cystoscopy procedure performed on march 25, 2013.After the sling placement, the patient complained of pelvic pain as well as pain in her left groin area that started in 2016.She had a hysterectomy in (b)(6) 2016.On (b)(6) 2022, the patient received a suburethral sling revision to address the problem.Boston scientific received an additional information on 23sep2022 as follows: it was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a hysterectomy, dilatation and curettage, hydrothermal ablation and mid urethral sling placement and cystoscopy procedure performed on march 25, 2013, for the treatment of menorrhagia failing medical management and stress urinary incontinence.After injection of the urethral area, the patient had an episode of hypertension that lasted less than 5 minutes.After the vaginal epithelial incision was made, there was a copious amount of bleeding requiring electrocautery.The increased blood pressure and bleeding were resolved, and the procedure continued.On (b)(6) 2021, the patient underwent a consultation at a clinic with the chief complaint of pain in her left groin.In the course of the patient's examination by a doctor in the said area, it was discovered that she had significant left groin pain.Since 2016, the patient claimed she had intermittent left-sided groin pain.She characterized it as being intense, sharp, occasionally tight, and severe enough to make activity difficult.The patient thought her sciatic nerve was causing behind her pain.Moreover, a vaginal exam was performed and found there was no extrusion noted, but there was a left peri-urethral tenderness to palpation at the left obturator internus sling insertion point.After her assessment in september, she claimed that her pain was consistent and that the sling had only provided temporary relief.She also claimed that she experienced pain twice a week.On (b)(6) 2021, she also had a pelvic ultrasound, which revealed a 1.5 x 2.6 x 1.2 cm stable left ovarian cyst.Her doctor advised her to return in 6 to 8 months for a follow-up image.The patient reported voiding every 2 hours during the day and twice during the night, urinary urgency, loss of urine with urgency with dribbling, loss of urine with cough/sneeze/laugh.Furthermore, the patient was found to have mixed urinary incontinence, pelvic pain, rectocele, and incomplete bladder emptying during the consultation.On (b)(6) 2022, the patient returns in the clinic with continued complaints of urinary incontinence, urinary urgency and pelvic pain.Prior to the patient's consultation, she underwent urodynamics procedure on (b)(6) 2022, and (b)(6) 2022, and the findings are as follows: urodynamic date: (b)(6) 2022 uroflowmetry with 15 ml uniphasic and postvoid residuals.Stress urinary incontinence was noted without prolapse reduction at 150 ml.The valsalva leak point pressure was 46 cm h20.Mean urethral closure pressures were normal (93 cm h20) without prolapse reduction.There was no evidence of intrinsic sphincter deficiency.Detrusor instability at 151 ml.Urodynamic b date: (b)(6) 2022.Bladder sensation was normal (220 ml), and bladder capacity was decreased (341 ml).Stress urinary incontinence was not noted.Detrusor instability was not noted at 341 ml.The voiding mechanism was normal.The postvoid residual was 150 ml.A cystoscopy of the bladder was also conducted using a 70-degree panendoscope, that revealed trabeculation.It was also observed that straining or coughing resulted in +1 transillumination of the bladder.A genitourinary examination was also performed, which revealed +1 periurethral tenderness to palpation at the location where the sling was inserted.She also has urgency and urgency leakage.An elevated post-void residue was also observed.The doctor had discussed about sling revision and the implantation of a new suburethral sling.The doctor also thoroughly discussed the patient's urodynamics testing and cystoscopy findings.There was urethral tenderness, a decreased bladder capacity (350 ml), and stress incontinence.They also went through all of the therapy options, including pessary or surgical correction.The patient wishes surgical correction in the form of a sling revision and suburethral sling with tension-free vaginal tape.It has also been thoroughly discussed the risks of the surgery, which include organ damage, infection, and bleeding.The patient was counseled on preoperative and postoperative preparation.To address recurrent mixed urinary incontinence and pelvic pain, the patient underwent a revision of the suburethral sling, placement of a retropubic suburethral sling, and cystoscopy on (b)(6) 2022.Exam under anesthesia revealed some urethral mobility.Intraoperative findings showed a suburethral sling with some tensioning noted on the distal urethra but cystoscopic examination at the end of the procedure showed no bladder and no urethral trauma.During the surgery, the patient was carefully prepped and draped in a standard method so that there was no excessive knee bending or lateral leg compression in the low or high lithotomy position.The lone start retractor was used for visualization once everything had been properly prepped and draped.The urethral area was assessed.The previous operation site was injected with a lidocaine, marcaine, and epinephrine solution.A 15-blade scalpel was used to make an incision in the mucosa near the kidney, about 1 cm proximal to the urethral meatus.The mucosal margins were gripped with an allis clamp at this point, and periurethral dissection was performed on the right side with metzenbaum scissors.For visualization, the lone star retractor was used.The dissection was then handled carefully.The finding of the sling mesh was difficult.Sharp dissection revealed an area of indentation all the way to the distal area, consistent with a possible mesh sling.The sling was identified after area was carefully dissected free with sharp dissection.It was separated from the urethra after being undermined.A kocher clamp was used to secure the edges.It was then cut in the middle and separated into two arms on each side, right and left.As much as possible, dissection was performed laterally, and the sling was trimmed in each area.The prior sling bed was reconstructed with 3-0 vicryl interrupted sutures at this point, bringing the edges of the endopelvic fascia together and closing off this area.Interrupted 2-0 vicryl sutures were also used for hemostasis as needed.After that, the suprapubic area was marked with a ruler and noted in the midsagittal plane, allowing the sagittal plane to be 2 cm away from the midsagittal plane.The retzius space was hydrodissected using a 20-gauge spinal needle and a 30-cc syringe filled with 0.5% lidocaine and epinephrine solution.The focus then shifted to the dissection site.The catheter guide deviated the urethra to the patient's left, while the tvt trocar was implanted in the right periurethral dissection plane.The trocar device was gently advanced behind the pubic bone, aiming for the patient's ipsilateral shoulder.It was important to hug the pubic bone, go around it, not deviate laterally, and come out in 2 cm of midsagittal plane.A 70-degree scape cystoscopy showed no bladder or urethral damage.These maneuvers were repeated in a similar fashion on the opposite side.A repeat cystoscopy revealed no bladder or urethral damage.Mayo scissors were used to elevate the tape sheets and separate them from the urethra.Each tape sheet was removed separately.The application was tension-free.A 5cc floseai was put in each periurethral dissecting area to ensure hemostasis.The wound was subsequently closed with a 2-0 vicryl running lock suture.Dissection was associated with two periurethral windows.These were closed with interrupted 2-0 vicryl sutures.Hemostasis was appreciated.The procedure was well tolerated by the patient, who was brought to the recovery room in stable condition with a foley catheter in place.Pathology of the explanted vaginal sling shoed detached fragments of connective fibrous tissue with mild chronic inflammation and mesh.

• 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: 14682269
• MDR Text Key: 294040987
• Report Number: 3005099803-2022-03292
• 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,Followup,Followup
• Report Date: 11/22/2022

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: 01/31/2015
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: ML00000484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 09/23/2022; 10/27/2022
• Supplement Dates FDA Received: 10/19/2022; 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female