MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT BLUE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068502120

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Erosion (1750); Micturition Urgency (1871); Headache (1880); Nausea (1970); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Dizziness (2194); Urinary Frequency (2275); Numbness (2415); Neck Pain (2433); Dysuria (2684); Constipation (3274); Convulsion/Seizure (4406); Dyspareunia (4505); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/23/2022

Event Type  Injury  

Manufacturer Narrative

Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6) general surgery block h6: the following imdrf patient codes capture the reportable events of: e2330 - pain e2006- mesh erosion e1309 - urinary retention e0116 - headache e0127 - numbness e1301 - dysuria e1405 - dyspareunia e0109 - seizure e1002 - abdominal pain e1623 - neck pain e2402 - distention imdrf impact code f2303 captures the reportable event of the medications prescribed to the patient.

Event Description

It was reported to boston scientific that an advantage fit system was implanted into the patient during a synthethic mid-urethral sling, anterior repair, and cystoscopy procedure performed on (b)(6) 2020, for the treatment of stress urinary incontinence and a stage ii cystocele.During the procedure, cystoscopy was performed an no bladder injuries were observed, there was good ureteral spill of urine bilaterally, and good sling placement.There was good hemostasis at the end of the procedure.The vagina was irrigated.The patient tolerated the procedure well and was sent to the recovery room in stable condition.In 2020, the patient experienced erosion with the sling device and planned to start a vaginal estrogen cream; however, the patient could not recall if the treatment was attempted or not.On (b)(6) 2022, the patient presented for evaluation of erosion of the suburethral sling and recurrent urinary incontinence.The patient noted vaginal pain when sitting, pain in urethra, dysuria, and dyspareunia during insertion.It was noted that the mesh erosion-related symptoms had significantly worsened since the last appointment, and the patient tried azo, which was somewhat helpful.The patient indicated rarely experiencing stress urinary incontinence; however new symptoms of urinary frequency and urgency had developed.She felt her urinary stream was slower than it was before the sling implant, accompanied with a feeling of incomplete emptying at times.The patient tended toward constipation but denied straining or stool trapping.During review of systems, the patient was positive for abdominal distention, abdominal pain, nausea, difficulty urinating, dyspareunia, dysuria, frequency, urgency, vaginal discharge, vaginal pain, neck pain, dizziness, seizures, numbness, and headaches.Her current medications included emgality 120 mg/ml, keppra 750 mg, melatonin 5 mg, mobic 15 mg, zanaflex 4 mg, synthroid 100 mcg, gabapentin 400 mg, and rizatriptan 10 mg.During physical examination, one centimeter of vaginal erosion in the midline was noted.There was no tenderness with palpation over the pelvic floor muscles; however, bilateral tenderness in the fornices was noted.The tenderness was higher on the left fornix than the right.The assessment included erosion of suburethral sling, sequela, stress urinary incontinence (sui), female, overactive bladder (oab), feeling of incomplete bladder emptying, and voiding dysfunction.The diagnosis and pathophysiology therapeutic options were discussed at lengths, including risks, benefits, and alternatives.The patient indicated the discomfort related to the erosion had significantly increased; therefore, opting to proceed with the surgery.The patient was aware that she will need ongoing evaluation and treatment of any new, persistent, or worsening urinary incontinence symptoms after surgery.This may involve behavioral management, physical therapy, medications, or surgery.All questions were answered during the appointment and the patient felt comfortable with the plan.

• Brand Name: ADVANTAGE FIT BLUE SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18735510
• MDR Text Key: 335694599
• Report Number: 2124215-2024-09096
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• 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: 02/19/2024

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: 02/09/2023
• Device Model Number: M0068502120
• Device Catalogue Number: 73189
• Device Lot Number: 0025186791
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2020
• 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: 41 YR
• Patient Sex: Female