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 Adhesion(s) (1695); Arrhythmia (1721); Erosion (1750); Calcium Deposits/Calcification (1758); Chest Pain (1776); Micturition Urgency (1871); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Discomfort (2330); Prolapse (2475); Dysuria (2684); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Skin Inflammation/ Irritation (4545); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 12/09/2016

Event Type  Injury  

Manufacturer Narrative

Date of event is approximated to (b)(6) 2016, date when the device was implanted.The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date is unknown.This event was reported by the patient's legal representation.The implanting surgeon is (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a solyx sis system was implanted on (b)(6) 2016.As reported by the patient's attorney, she suffered pain, mental anguish, erosion, dyspareunia, urinary dysfunction, infection, scarring and loss of enjoyment of life.Moreover, the patient had to undergo revision surgeries.

Manufacturer Narrative

Blocks a2, b5, h6: patient codes and h6: impact codes have been updated based on the additional information received on november 4, 2022 block a2: date of birth was updated.Block b5 was updated.Block h6 was updated.Block b3: date of event is approximated to (b)(6), 2016, date when the device was implanted.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date is unknown.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is dr.(b)(6).(b)(6), united states.Block h6: the following imdrf patient codes capture the reportable events below: e2006 - mesh erosion e2101 - adhesions e2330 - pain e1405 - dyspareunia e1715 - scar tissue e0206 - mental anguish e1906 - infection impact code f1905 captures the reportable event of device revision.Impact code f12 has been used in the light of the patient had filed a legal claim for patient complications related to the device.

Event Description

It was reported to boston scientific corporation that a solyx sis system was implanted on (b)(6), 2016.As reported by the patient's attorney, she suffered pain, mental anguish, erosion, dyspareunia, urinary dysfunction, infection, scarring and loss of enjoyment of life.Moreover, the patient had to undergo revision surgeries.Additional information as of november 04, 2022, on (b)(6), 2016, a solyx single incision sling was implanted during a mid urethral sling placement and cystoscopy procedure for the treatment of stress urinary incontinence.On (b)(6), 2017, the patient was seen for follow-up check.History of present illness includes stress urinary incontinence and nocturia.She was placed on toviaz 4mg daily for overactive bladder; however, at this point, she is still having uti symptoms and reports irritation where the sling was placed.On (b)(6) 2017, the patient underwent a cystoscopy.Cystoscopy revealed that the urethra and bladder neck appear to be normal.No stones, lesions and no evidence of perforation found in the bladder.An anterograde cystoscopy was also performed, and it was found out that there is a small sling erosion in the urethra; however, due to the low pressure of the flexible scope, the urethra was unable to fully distend.A follow-up cystoscopy will be set up with possible sling extraction and foley catheter placement on (b)(6), 2017, the patient underwent cystoscopy procedure under anesthesia with a preoperative diagnosis of incontinence and possible sling erosion.Upon cystoscope examination there was no evidence of sling extrusion found.The patient's bladder was drained.The patient was transferred to the recovery room and in stable condition, to be discharged home.On (b)(6), 2020, patient had an office visit for vulvar lump evaluation.The patient noticed the lump two months prior to the visit and described it as a three-centimeters lump.The identified aggravating factor is mesh placement.No alleviating factors have been identified.She has not had a previous colonoscopy for this condition.The lesions have not been biopsied.The patient has been previously treated with transvaginal mesh, urethral prolapse on january 1, 2017.Assessment of this visit included erosion of bladder suspension mesh with a very thin layer of mucosa overlying the mesh.Aggressive vaginal estrogen treatment is recommended and will be re-evaluated in three months.On (b)(6), 2021, office visit vaginal mesh exposure.The symptom of the patient includes stress urinary incontinence (sui) and symptomatic dyspareunia and vaginal mesh exposure.Reports urinary incontinence when coughing, sneezing, lifting, activity with occasional spasms.The patient mentioned that sling did not improve sui.Within the last year, patient felt mesh like material in vagina and partner can feel it as well.Impressa was then attempted to use for sui treatment; however, pain was noted during insertion.On (b)(6), 2021, the patient underwent cystourethroscopy, vaginal mesh excision and urethroplasty for the treatment of persistent stress urinary incontinence, vaginal mesh exposure and dyspareunia.A foley catheter was placed during the procedure and was planned to be removed approximately two weeks from the procedure.Finding includes, atrophic vaginal tissue, sling adherent to urethra with urethral defect noted upon sling excision, all palpable sling excised successfully, and urethral defect closed with multiple layers.The patient tolerated the procedure well.On (b)(6), 2021, office visit for foley catheter removal.Patient voided 217 cc.On (b)(6), 2022, patient reported severe sui since removal of foley catheter.She is wearing six- seven pads, reports constant leaking with all activities, including standing.On (b)(6), 2022, patient present for cystoscopy and surgery discussion for excision, urethroplasty, and cystoscopy that was done on (b)(6), 2021.Cystoscopy finding reveals normal cystoscopy (bladder- urethral bilateral).On (b)(6), 2022, the patient underwent cystourethroscopy, foley catheter placement, and autologous fascial sling placement with rectus fascial harvest.The pre-operative and post operative diagnosis for the procedure are recurrent stress urinary incontinence, history of prior synthetic urethral sling and history of vaginal mesh erosion status post excision and urethroplasty.On (b)(6), 2022, office visit for acute vaginal bleeding.Endorses bleeding volume similar to a moderate menstruation.Wearing 3 pads daily for bleeding, denies sui after fascial sling.Reports abdominal incision healing well, denies drainage.Prior to visit, patient complains of intermittent vaginal spotting and low-grade fevers.Patient reports that her sui has resolved.Medications: keflex 750 mg capsule, 1 capsule twice a day.On (b)(6), 2022, office visit for sui post autologous fascial sling and harvest of rectus abdominis fascia.She had vaginal bleeding following surgery until (b)(6), 2022, and it then stopped until (b)(6), 2022, when she had recurrence of vaginal spotting requiring her to wear 1 pad per day.She feels that she has had a 75% improvement in her sui.And only wears pads for safety when doing strenuous work.She voids three times daily, nocturia zero to one time.No hematuria.Feels like she has to push to empty her bladder.

Manufacturer Narrative

Blocks b5, h6: patient codes and h6: impact codes have been updated based on the additional information received on september 12, 2023.Block b3: date of event is approximated to december 09, 2016, date when the device was implanted.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date is unknown.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is (b)(6).Block h6: the following imdrf patient codes capture the reportable events below: imdrf patient codes e2006 capture the reportable event of mesh erosion.Imdrf patient codes e2101 capture the reportable event of adhesions.Imdrf patient codes e2330 capture the reportable event of pain.Imdrf patient codes e1405 capture the reportable event of dyspareunia.Imdrf patient codes e1715 capture the reportable event of scar tissue.Imdrf patient codes e0206 capture the reportable event of mental anguish.Imdrf patient codes e1906 capture the reportable event of infection.Imrdf impact code f1905 captures the reportable event of device revision.Imrdf impact code f12 has been used in the light of the patient had filed a legal claim for patient complications related to the device.Imdrf patient codes e1301 capture the reportable event of dysuria.Imdrf patient codes e2320 capture the reportable event of hypertension.Imdrf patient codes e0601 capture the reportable event of ventricular tachycardia.Imdrf patient codes e1310 capture the reportable event of urinary tract infection.Imdrf patient codes e1720 capture the reportable event of irritation.Imdrf patient codes e2401 capture the reportable event of vulval lump.Imdrf patient codes e2333 capture the reportable event of prolapse.Imdrf patient codes e2015 capture the reportable event of atrophy.Imdrf patient codes e233001 capture the reportable event of chest pain.Imdrf patient codes e230901 capture the reportable event of nephrolithiasis- kidney stones and renal calculi.Imrdf impact code f23 captures the reportable event of unexpected medical intervention.

Event Description

It was reported to boston scientific corporation that a solyx sis system was implanted on (b)(6) 2016.As reported by the patient's attorney, she suffered pain, mental anguish, erosion, dyspareunia, urinary dysfunction, infection, scarring, and loss of enjoyment of life.Moreover, the patient had to undergo revision surgeries.Additional information as of november 04, 2022 on (b)(6) 2016, a solyx single incision sling was implanted during a mid urethral sling placement and cystoscopy procedure to treat stress urinary incontinence.On (b)(6) 2017, the patient was seen for a follow-up check.History of present illness includes stress urinary incontinence and nocturia.She was placed on toviaz 4mg daily for overactive bladder; however, at this point, she is still having urinary tract infection (uti) symptoms and reports irritation where the sling was placed.On (b)(6) 2017, the patient underwent a cystoscopy.Cystoscopy revealed that the urethra and bladder neck appear to be normal.No stones, lesions, and no evidence of perforation found in the bladder.An anterograde cystoscopy was also performed, and it was found out that there is a minor sling erosion in the urethra; however, due to the low pressure of the flexible scope, the urethra was unable to distend fully.A follow-up cystoscopy will be set up with possible sling extraction and foley catheter placement on (b)(6) 2017, the patient underwent a cystoscopy procedure under anesthesia with a preoperative diagnosis of incontinence and possible sling erosion.Upon cystoscope examination, there was no evidence of sling extrusion found.The patient's bladder was drained.The patient was transferred to the recovery room and in stable condition to be discharged home.On (b)(6) 2020, the patient had an office visit for vulvar lump evaluation.The patient noticed the lump two months before the visit and described it as a three-centimeter lump.The identified aggravating factor is mesh placement.No alleviating factors have been identified.She has not had a previous colonoscopy for this condition.The lesions have not been biopsied.The patient was previously treated with transvaginal mesh, urethral prolapse on (b)(6) 2017.Assessment of this visit included erosion of bladder suspension mesh with a very thin layer of mucosa overlying the mesh.Aggressive vaginal estrogen treatment is recommended and will be re-evaluated in three months.On (b)(6) 2021, office visit vaginal mesh exposure.The symptom of the patient includes stress urinary incontinence (sui) and symptomatic dyspareunia and vaginal mesh exposure.Reports urinary incontinence when coughing, sneezing, lifting, activity with occasional spasms.The patient mentioned that sling did not improve sui.Within the last year, patient felt mesh like material in vagina and partner can feel it as well.Impressa was then attempted to use for sui treatment; however, pain was noted during insertion.On (b)(6) 2021, the patient underwent cystourethroscopy, vaginal mesh excision and urethroplasty for the treatment of persistent stress urinary incontinence, vaginal mesh exposure and dyspareunia.A foley catheter was placed during the procedure and was planned to be removed approximately two weeks from the procedure.Finding includes, atrophic vaginal tissue, sling adherent to urethra with urethral defect noted upon sling excision, all palpable sling excised successfully, and urethral defect closed with multiple layers.The patient tolerated the procedure well.On (b)(6) 2021, office visit for foley catheter removal.Patient voided 217 cc.On (b)(6) 2022, patient reported severe sui since removal of foley catheter.She is wearing six- seven pads, reports constant leaking with all activities, including standing.On (b)(6) 2022, patient present for cystoscopy and surgery discussion for excision, urethroplasty, and cystoscopy that was done on (b)(6) 2021.Cystoscopy finding reveals normal cystoscopy (bladder- urethral bilateral).On (b)(6) 2022, the patient underwent cystourethroscopy, foley catheter placement, and autologous fascial sling placement with rectus fascial harvest.The pre-operative and post operative diagnosis for the procedure are recurrent stress urinary incontinence, history of prior synthetic urethral sling and history of vaginal mesh erosion status post excision and urethroplasty.On (b)(6) 2022, office visit for acute vaginal bleeding.Endorses bleeding volume similar to a moderate menstruation.Wearing 3 pads daily for bleeding, denies sui after fascial sling.Reports abdominal incision healing well, denies drainage.Prior to visit, patient complains of intermittent vaginal spotting and low-grade fevers.Patient reports that her sui has resolved.Medications: keflex 750 mg capsule, 1 capsule twice a day.On (b)(6) 2022, office visit for sui post autologous fascial sling and harvest of rectus abdominis fascia.She had vaginal bleeding following surgery until (b)(6) 2022, and it then stopped until (b)(6) 2022, when she had recurrence of vaginal spotting requiring her to wear 1 pad per day.She feels that she has had a 75% improvement in her sui.And only wears pads for safety when doing strenuous work.She voids three times daily, nocturia zero to one time.No hematuria.Feels like she has to push to empty her bladder.As reported by the patient's attorney, she suffered pain, mental anguish, erosion, dyspareunia, urinary dysfunction, infection, scarring and loss of enjoyment of life.Moreover, the patient had to undergo revision surgeries.Additional information as of september 12, 2023 on (b)(6) 2017, the patient had a visit and reports that she still has some incontinence.It is said to be difficult to ascertain whether it is a stress versus an urge urinary incontinence.The patient was assessed and found to have stress urinary incontinence and nocturia.A trial of toviaz 4 mg daily was given to the patient and asked to be back after two weeks for next checkup.The patient came for a follow up and was set up for cystoscopy on november 3, 2020.During cystoscopy procedure, an antegrade cystoscopy was performed and found to have small sling erosion in the urethra.However, due to the low pressure of the flexible scope, they are unable to fully distend the urethra.The next year, (b)(6) 2021, the patient had an office visit as she claims to have detached bladder mesh and thinks she has bladder infection.During assessment, the patient was found to have dysuria, chronic pain, essential hypertension, tachycardia, chest pain and complication of implant vaginal mesh.The treatment for the mentioned diagnosis were routine labs, electrocardiogram (ekg), urinalysis, additional medication, imaging, intervention for depression screening.After three months, specifically, (b)(6) 2021, the patient had another office visit.As previously noted on cystoscopy and pelvic examination, she did have evidence of mesh erosion on the right side at the vaginal sulcus.She continues to wear 2-3 pads per day, and this does not decrease since the sling was placed.The problem listed during assessment were kidney lesion, urinary tract infection with pyuria, nephrolithiasis, urinary incontinence, essential hypertension and tachycardia.The patient does not have urethral hypermobility and she has evidence of mesh erosion associated with single incision sling.Both her urinary symptoms as well as mesh erosion are bothersome to her.A plan for repeat stress urinary incontinence procedure was made.

• 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: 15744127
• MDR Text Key: 303163937
• Report Number: 3005099803-2022-06523
• 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: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2023
• 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; Other
• Patient Age: 50 YR
• Patient Sex: Female