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 Erosion (1750); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Obstruction/Occlusion (2422); Dysuria (2684); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is approximated to (b)(6) 2020, date when the device was implanted.This event was reported by the patient's legal representation.The implanting surgeon is dr.(b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a solyx sis system was implanted on (b)(6) 2020.As reported by the patient's attorney, she suffered she suffered pain, dyspareunia, chronic pain, urinary dysfunction, mesh exposure, mesh erosion, scarring and loss of enjoyment of life.Moreover, the patient had to undergo revision surgeries.

Event Description

It was reported to boston scientific corporation that a solyx sis system was implanted on (b)(6) 2020.As reported by the patient's attorney, she suffered she suffered pain, dyspareunia, chronic pain, urinary dysfunction, mesh exposure, mesh erosion, scarring and loss of enjoyment of life.Moreover, the patient had to undergo revision surgeries.The procedures performed on (b)(6) 2020 were examination under anesthesia, diagnostic laparoscopy, laparoscopic bilateral salpingo-oophorectomy, and solyx sling placement.The patient had sling mesh exposure.On (b)(6) 2020, the patient underwent examination under anesthesia and revision and partial removal of sling.Operative findings include a piece of mesh was noted to be exposed at the right area of the anterior vaginal mucosa.On (b)(6) 2021, the patient underwent pubovaginal sling with mesh due to stress urinary incontinence.

Manufacturer Narrative

Block b3: date of event is approximated to september 02, 2020, date when the device was implanted.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is (b)(6).Block h6: patient codes e2330, e2006, e1715 and e0206 captures the reportable events of pain, urinary problems, erosion and extrusion, scar tissue and unspecified mental, emotional or behavioral problem.Impact codes f1905 and f12 captures the reportable event of device revision and serious injury.Block h11: block a2 (date of birth) and block b5 were updated.

Event Description

It was reported to boston scientific corporation that a solyx sis system was implanted on (b)(6) 2020.As reported by the patient's attorney, she suffered pain, dyspareunia, chronic pain, urinary dysfunction, mesh exposure, mesh erosion, scarring, and loss of enjoyment of life.Moreover, the patient had to undergo revision surgeries.Additional information as of december 20, 2022.The procedures performed on (b)(6) 2020, were examination under anesthesia, diagnostic laparoscopy, laparoscopic bilateral salpingo-oophorectomy, and solyx sling placement.The patient had sling mesh exposure.On (b)(6) 2020, the patient underwent examination under anesthesia, revision, and partial sling removal.Operative findings include a piece of mesh noted to be exposed at the right area of the anterior vaginal mucosa.On (b)(6) 2021, the patient underwent a pubovaginal sling with mesh due to stress urinary incontinence.Additional information as of september 12, 2023.On (b)(6) 2020, the patient was diagnosed with fragments of granulation tissue with acute and chronic inflammation and underwent a removal of urinary sling.The patient had a follow-up visit on (b)(6) 2021.History of present illness includes stress incontinence, which she finds very bothersome.She then proceeds with a female cystoscopy procedure.The patient tolerated the procedure well.Another follow-up visit was made on (b)(6) 2021, as the patient stated that partner complained of a rough area in the vagina and had sling complications.Physical examination revealed mild erosion in the bladder neck region of the vagina and healthy appearing tissue with mild inflammation.The final diagnosis includes mixed incontinence, foreign body in the bladder, sequela, mixed incontinence, and sling erosion.On (b)(6) 2021, the patient had her subsequent follow-up visit and was diagnosed with vaginal erosion due to surgical mesh, foreign body in the bladder, sequela, mixed incontinence, and sling erosion.Due to the following diagnosis, the patient would like a sling removal or replacement.The following year, specifically on (b)(6) 2022, the patient stated that stress incontinence had returned and was not better.She also complains of vaginal pain and claims her sexual partner feels mesh in the vagina.On the same date, the patient had a phone call stating he had uti symptoms again and requested medication and a refill on ambien.She saw another urogynecologist and was told that she could not do the hysterectomy and remove the mesh that was implanted because mesh becomes blended with skin and will cause major damage.The patient decided to follow up with previous urology and request if they could repair the mesh.On (b)(6) 2022, the patient had an appointment as she experienced uti symptoms: lower back pain for the past three days and many utis.She also stated that she finished the course on macrobid that we gave on (b)(6) 2022 and has not noticed improvement.The patient was assessed and found to have a urinary tract infection (site not specified), dysuria, and calculus of the kidney.

Manufacturer Narrative

Blocks b5 and h6 (patient and impact codes) have updated based on the additional information received on september 12, 2023.Block b3: date of event is approximated to (b)(6) 2020, date when the device was implanted.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is dr.(b)(6).Block h6: patient codes e2330, e2006, e1715 and e0206 captures the reportable events of pain, urinary problems, erosion and extrusion, scar tissue and unspecified mental, emotional or behavioral problem.Impact codes f1905 and f12 captures the reportable event of device revision and serious injury.Imdrf patient codes e2326 capture the reportable event of acute and chronic inflammation.Imdrf patient codes e1310 capture the reportable event of foreign body in bladder.Imdrf patient codes e1301 capture the reportable event of dysuria.Imdrf patient codes e2328 capture the reportable event of calculus of kidney.Imrdf impact code f2203 captures the reportable event of cystoscopy and imaging (ultrasound).Imrdf impact code f2303 captures the reportable event of another course of antibiotics.

• 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: 15744876
• MDR Text Key: 303172296
• Report Number: 3005099803-2022-06524
• 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: 10/10/2023

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 Expiration Date: 06/16/2022
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0023963429
• 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
• Date Device Manufactured: 06/17/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female