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

Model Number M0068502110

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

Patient Problems Fatigue (1849); Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Burning Sensation (2146); Prolapse (2475); Urinary Incontinence (4572)

Event Date 09/01/2015

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage fit device was implanted into the patient during a procedure performed on (b)(6) 2012 for the treatment of stress urinary incontinence and detrusor overactivity.The patient had initially a good response after the procedure but she came back in 2015 where urodynamics showed detrusor over activity.She went into the believe study and was then given with mirabegron.She then developed chronic fatigue syndrome and had some symptoms of worsening of prolapse which was noted right from the start.She had an anterior and posterior repair for a large cystocele and rectocele performed in (b)(6) 2015.She was doing well at the postoperative visit later in 2015.She was reviewed in (b)(6) 2016 when she was taking mirabegron and she had reasonable control.She came back to the clinic in 2018 with chronic pelvic and groin pain.She had a normal flexible cystoscopy under urology.She initially responded to depo-medrone and chirocaine injection but her symptoms recurred.On (b)(6) 2019, she had an excision of the left sided suprapubic aspect of the mesh from the skin down to the sheath.She was treated with some imipramine.She was seen by the local pain team on (b)(6) 2019.Repeat urodynamic tests on (b)(6) 2019 showed detrusor over activity.She had been using her pregabalin.Tolterodine 2 mg was advised to be taken with mirabegron and she was considered for intravesical botox treatment.She had her recurrent prolapse treated with an anterior repair with repeat injection of the depo-medrone and chirocaine in (b)(6) 2020.This helped with the prolapse.She had further input form the chronic pain team in (b)(6) 2020.Furthermore, she had a diagnosis of chronic fatigue syndrome/fibromyalgia and urgency.She gets the pain specifically in the morning when the bladder is full.She describes a hot sensation when the bladder is full.On (b)(6) 2022, the patient presented for an mri due to chronic right groin and suprapubic pain.Findings showed the mesh in its original place.No evidence of erosion, no collection or tape related complications.On (b)(6) 2022, the patient presented due to mesh complications as referred by her gynecologist.The mesh complications included: right pelvic pain and suprapubic pain.Main point was over scar.Worse in the morning.On bladder filling, walking, night and morning.Effect gait -- felt impacting right knee by over compensating.Still has some left groin pain.Recurrent utis.Managed locally.Luts (lower urinary tract symptoms).Stress urinary incontinence/urinary urgency.Incomplete emptying, associated with pain.Urge worse at night/morning.Plan: stay as is with pain/psychology support.Partial/vaginal mesh removal.Total mesh removal.On (b)(6) 2022, the patient had multidisciplinary review meeting.She was offered with pain and psychology assessments, referral to bariatric services and tgjtc in twelve months.Mdt outcomes: surgical plan.Pain management plan.Clinical psychology plan.Nursing plan.Imaging plan.Admin/managerial plan.Letter to patient and gp organized.Further mdt required.

Manufacturer Narrative

Patient identifier: as per eu gdpr (general data protection regulation), only the patient's weight, gender, and age can be reported in any regulatory report.Thus, the patient's initials and date of birth will not be documented.Date of event: the exact event onset date is unknown.The provided event date of september 1, 2015 was chosen as a best estimate based on the date of anterior and posterior repair.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).

• Brand Name: ADVANTAGE FIT 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15906263
• MDR Text Key: 304726495
• Report Number: 3005099803-2022-07173
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2022
• 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: 51 YR
• Patient Sex: Female