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 Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Prolapse (2475); Dysuria (2684); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 03/08/2022

Event Type  Injury  

Event Description

This report pertains to one of four devices used for the same patient.It was reported to boston scientific corporation that a solyx sis system and an upsylon y mesh were used during a robotic-assisted abdominal sacrocolpopexy, cystocele, rectocele, enterocele repair, sling and cystoscopy procedures performed on (b)(6) 2021 to treat a patient with vaginal vault prolapse, cystocele and rectocele.The patient had a grade 2 to 3 vaginal wall prolapse.The patient had history of repair in the past but has had recurrence even with synthetic mesh.The patient was asked to avoid lifting, straining, pushing or pulling.The patient was considering a surgical intervention.In the physician's assessment, the patient had vaginal vault prolapse, cystocele, rectocele, overactive bladder and incontinence.The patient was brought to recovery in stable condition.The excised old mesh was sent to pathology for gross examination.An elongated portion of the blue interwoven plastic with adherent tan-brown friable tissue, suggestive of mesh was 9.2 x 0.4 x 0.2 cm.On (b)(6) 2022, the patient was seen and examined for urgency, frequency and incontinence.The patient has issues with diabetic control and glucose control.The patient was also seen for a follow up status post colpopexy, sling and cystoscopy.The patient reported to use five to six pads daily for stress incontinence.The patient did not report any bowel movement problems.The patient reported occasional dysuria the previous month but none lately.In the physician's assessment, the patient has cystocele, other microscopic hematuria (glucosuria only) but has resolved, unspecified urinary incontinence, gastro-esophageal reflux disease with esophagitis and type 2 diabetes mellitus without complications.On (b)(6) 2022, the patient sought consult for pelvic pain and urinary incontinence.The patient also reported dysuria and she felt that something was tearing.The patient continued to have urinary incontinence.She stated that she did have stress incontinence but also has significant urgency incontinence with urgency being more bothersome.The patient tried oxybutynin, which caused dry mouth without improving her symptoms.The patient also reported to have some pain with intercourse.The patient was taking ibuprofen, hydrocodone and oxycodone for her pain management.Given the patient's symptoms, in the physician's assessment, the patient needed multichannel urodynamics for further evaluation of her bladder function.However, in order to offer any surgical treatment the physician advised that she would have to get better control of her diabetes.The physician recommended for the patient to consider a less invasive approach with bulking agents such as bulk amid.As for the patient's significant urgency incontinence, trospium was prescribed to see if this will improve her symptoms.The patient did have a myofascial component to her pain.The physician recommended starting with pelvic floor physical therapy given her poorly controlled diabetes.If the patient was able to control her diabetes better, the physician would consider whether partial mesh removal of the anterior vaginal wall would be appropriate.A cystoscopy was also recommended to evaluate her bladder to ensure that there was no other mesh erosion protruding into the bladder.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6), md.(b)(6) medical center usa.(b)(4).

Manufacturer Narrative

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: (b)(6).Block h6: patient code e232402 captures the reportable event of "frequency." patient code e2330 capture the reportable events of "pelvic pain," and "myofascial component to her pain." patient code e1405 capture the reportable event of "reported to have some pain with intercourse." patient code e1301 capture the reportable events of "reported occasional dysuria," and "dysuria." impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h11: blocks b5, b7, h6, and h10 have been updated based on the additional information received on november 15, 2022.Block h6: patient code e1310 captures the reportable event of "urinary tract infection.".

Event Description

Note: this report pertains to one of four devices used for the same patient.It was reported to boston scientific corporation that a solyx sis system and an upsylon y mesh were used during a robotic-assisted abdominal sacrocolpopexy, cystocele, rectocele, enterocele repair, sling and cystoscopy procedures performed on (b)(6) 2021 to treat a patient with vaginal vault prolapse, cystocele and rectocele.The patient had a grade 2 to 3 vaginal wall prolapse.The patient had history of repair in the past but has had recurrence even with synthetic mesh.The patient was asked to avoid lifting, straining, pushing or pulling.The patient was considering a surgical intervention.In the physician's assessment, the patient had vaginal vault prolapse, cystocele, rectocele, overactive bladder and incontinence.The patient was brought to recovery in stable condition.The excised old mesh was sent to pathology for gross examination.An elongated portion of the blue interwoven plastic with adherent tan-brown friable tissue, suggestive of mesh was 9.2 x 0.4 x 0.2 cm.On (b)(6) 2022, the patient was seen and examined for urgency, frequency and incontinence.The patient has issues with diabetic control and glucose control.The patient was also seen for a follow up status post colpopexy, sling and cystoscopy.The patient reported to use five to six pads daily for stress incontinence.The patient did not report any bowel movement problems.The patient reported occasional dysuria the previous month but none lately.In the physician's assessment, the patient has cystocele, other microscopic hematuria (glucosuria only) but has resolved, unspecified urinary incontinence, gastro-esophageal reflux disease with esophagitis and type 2 diabetes mellitus without complications.On (b)(6) 2022, the patient sought consult for pelvic pain and urinary incontinence.The patient also reported dysuria and she felt that something was tearing.The patient continued to have urinary incontinence.She stated that she did have stress incontinence but also has significant urgency incontinence with urgency being more bothersome.The patient tried oxybutynin, which caused dry mouth without improving her symptoms.The patient also reported to have some pain with intercourse.The patient was taking ibuprofen, hydrocodone and oxycodone for her pain management.Given the patient's symptoms, in the physician's assessment, the patient needed multichannel urodynamics for further evaluation of her bladder function.However, in order to offer any surgical treatment the physician advised that she would have to get better control of her diabetes.The physician recommended for the patient to consider a less invasive approach with bulking agents such as bulk amid.As for the patient's significant urgency incontinence, trospium was prescribed to see if this will improve her symptoms.The patient did have a myofascial component to her pain.The physician recommended starting with pelvic floor physical therapy given her poorly controlled diabetes.If the patient was able to control her diabetes better, the physician would consider whether partial mesh removal of the anterior vaginal wall would be appropriate.A cystoscopy was also recommended to evaluate her bladder to ensure that there was no other mesh erosion protruding into the bladder.Additional information received on november 15, 2022.On (b)(6) 2022, the patient was seen and examined status post colpopexy, sling implant and cystoscopy procedures performed on (b)(6) 2021 and (b)(6) 2018.The patient has problems with diabetic control.The patient has urgency frequency and incontinence.The patient also reported occasional stress and urge incontinence.She used two pads daily and reported frequency, but sugars were not controlled.The patient reported hgba1c in 9 range.The patient denied gross hematuria.The patient reported dysuria and itching in the vaginal area and urinary tract infection was suspected.Upon review of symptoms, the patient experienced frequent urination and urinary incontinence.In the physician's assessment, the patient has cystocele at midline.The patient also had other microscopic hematuria.In addition, the patient was experiencing unspecified urinary incontinence, gastro-esophageal reflux disease without esophagitis and type ii diabetes mellitus without complications.The physician instructed the patient to use fiber and to avoid bending and lifting straining for the patient's cystocele.On exam, the patient had no significant prolapse but when she pushed, she did have a grade 1 cystourethocele despite use of mesh.The physician instructed the patient to continue kegel exercises.For the patient's other microscopic hematuria, the physician noted that the patient had no microscopic hematuria.The patient had a history of negative cystoscopy in the past.For the patient's unspecified urinary incontinence, the physician noted that the patient had urgency frequency or urge incontinence.The physician instructed the patient to use kegel exercise.Diet instructions were also given.If the problem persisted, the physician was considering further evaluation and see if placing any support under the bladder would improve her bladder dysfunction.

• 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: 15713781
• MDR Text Key: 302832770
• Report Number: 3005099803-2022-06450
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729784784
• 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
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• 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: 11/15/2022
• 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: 53 YR
• Patient Sex: Female