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); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Urinary Frequency (2275); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 06/03/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a solyx sis system and upsylon device were implanted during a robotic assisted abdominal sacrocolpopexy, cystoscopy, and cystocele/rectocele/enterocele repair procedure performed on (b)(6)2016, for the treatment of vaginal wall prolapse, cystocele, stress incontinence, overactive bladder, urgency and frequency.The patient also underwent hysterectomy and bilateral salpingectomy lysis of omental adhesions during the same procedure for the preoperative diagnosis of chronic female pelvic pain.It was also noted that the patient had "significant pelvic pain, vaginal pain, hip pain, etc." the patient tolerated the procedure well and was brought to recovery in stable condition.As reported by the patient's attorney, she suffered pain, disability and disfigurement post procedure.On (b)(6) 2021, she reported during a clinic visit having bleeding vaginally on and off for over a year, which has gotten worse over the last six months.She was also having painful intercourse and lower back pain.Physical exam revealed slight tenderness noted on speculum examination; 2 areas of mesh exposure on the vaginal cuff, one superior and one inferiorly about 4 x 5 mm in size each one, very friable and bleeding when touched with a q-tip.Assessment: vaginal bleeding post-hysterectomy.Status post sacrocolpopexy and bladder sling in 2017.Erosion of mesh through the vaginal cuff in two areas.Dyspareunia.Lower back pain.The plan was for the patient to be seen by a urogynecologist.On (b)(6) 2021, the patient presented for preanesthetic medical examination prior to the planned procedure.She reported a one-year history of vaginal bleeding and intermittent pelvic pain.These symptoms have been progressively worsening.She also reported urinary frequency.She was taking tylenol if needed.Recommendation: patient is medically optimized for planned procedure.On (b)(6) 2021, the patient underwent obg urodynamic studies due to vaginal mesh exposure.Findings include an abnormal uroflow (prolonged and interrupted) and reduced bladder capacity.There was no evidence of detrusor overactivity, stress urinary incontinence and there was normal post-void residual with no evidence of urinary retention.On (b)(6) 2021, the patient underwent vaginal examination under anesthesia, revision of vaginal mesh and rigid cystoscopy procedure to treat the vaginal mesh exposure.Reportedly, the case was substantially more difficult than usual because of significant effort and difficulty mobilizing and identifying anatomical structures due to altered surgical field secondary to previous surgery, distorted anatomy and inflammation.The mesh was excised both visually and palpably.No further mesh exposure could be detected in the anterior posterior apical vaginal tissues.Cystoscopy was performed with no evidence of inadvertent injury or diverticular stones.The patient was taken to recovery room in awake and stable condition.On (b)(6) 2021, the patient underwent pm trigger point injections of left abdominal wall and right abdominal wall to treat muscle spasm and pelvic floor tension myalgia.Ultrasound image guidance was used to localize target, identify at risk structures, and dynamically used to direct therapy to the target.The injected medications include 40mg steroid,4.5ml bupivacaine 0.5% (5mg/ml), 3.5ml lidocaine (20mg/ml) and 40 mg triamcinolone acetonide (40mg/ml).The patient tolerated the procedure well and there were no apparent complications.

Manufacturer Narrative

Date of event is approximated to (b)(6) 2021, date when the patient presented with vaginal mesh exposure.This event was reported by the patient's legal representation.The implanting surgeon is dr.(b)(6).(b)(4).

• 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: 15594253
• MDR Text Key: 301629032
• Report Number: 3005099803-2022-05941
• 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
• Report Date: 10/13/2022

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: 06/14/2019
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0019369863
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Race: White