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

Model Number M0068502111

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

Patient Problems Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Depression (2361); Numbness (2415); Dysuria (2684); Fibrosis (3167); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 08/30/2017

Event Type  Injury  

Manufacturer Narrative

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 (b)(6) 2017 was chosen as a best estimate based on the date the symptoms were first noted.This event was reported by the patient's legal representation.The implant surgeon was: dr.(b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on (b)(6) 2017 for the treatment of stress urinary incontinence.On august 30, 2017, it was reported that the patient suffered difficulty voiding and possible fibroids after advantage fit implant.The procedure cured her stress incontinence.No longer had urgency, but she did have difficulty passing urine.The sensation of incomplete emptying worsened through the course of day.On examination, she did have a palpable mass arising from the pelvis which would most likely be a fibroid.There was no residual on bladder scan.Management: intermittent self - catheterization, bladder diary for three days, and ultrasound pelvis.The patient returned to clinic on (b)(6) 2017.She has been performing self - catheterization for voiding difficulties.She reports that she does not always pass very much with the catheter and dislikes doing it.Her bladder diary showed a large fluid intake over 4 liters and a maximum bladder capacity of 900 mls.The physician advised reducing fluid intake to two liters per day.The patient was seen in clinic on (b)(6) 2017.Patient had reduced her excessive fluid intake, but she had not noticed much difference in her voiding and feeling of incomplete emptying.She occasionally catheterizes and the physician advised her to continue doing so.The patient will be placed on a waiting for division of tvt.On april 26, 2021, it was stated in a letter that the patient had advantage fit implanted at (b)(6) in (b)(6) 2017 for stress incontinence but she has had voiding problems ever since.She was reviewed by a gynecologist in (b)(6) 2018 with an overactive bladder and was advised to trial a course of mirabegron but did not help.Patient did not empty her bladder properly and hence had utis.She had to self - catheter at times when she cannot void which causes pain in her bladder.This ongoing bladder issues was affecting her daily and making her depressed.She was taking sertraline 150mgs daily and had been prescribed a small dose of amitriptyline to help her sleep.On (b)(6) 2021, patient found self - catheter very painful particularly on withdrawing the catheter and was very sore for a good while afterwards.Patient had some and a kidney infection a couple of months ago, which was treated with antibiotics.She was single and was not sexually active, but she would like these problems resolved as she would like to start dating.Patient stated there was numbness when masturbating.Appointment was scheduled on (b)(6) 2021, for the patient to have flexible cystoscopy; some bladder function tests and also a possible trans labial scan to look at the mesh.Patient had the mesh divided but had not made any difference to voiding function.Patient was not keen on tape removal at the moment.It suggested that patient should be referred for consideration of sns, sympathetic nervous system.On february 28, 2022, it was stated in a clinical note that the patient experienced voiding difficulties pos implant, chronic feeling of uti, pain on bladder filling, voids standing and fibromyalgia.She was then given trial of ciprofloxacin 250mg once a day for 4 weeks and was listed for trial of sacral neuromodulation.From a tape point of view, patient's main complaint was voiding dysfunction.She could be up every 15 minutes and it was exhausting.She also described pain on bladder filling and the constant feeling of cystitis which cultures were generally negative.Last year, she did have a prolonged course of ciprofloxacin for pyelonephritis and found this beneficial.Discussed the option of trialing her with a nerve evaluation to see if neuromodulation would benefit her voiding dysfunction.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15940935
• MDR Text Key: 305081490
• Report Number: 3005099803-2022-07263
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729784777
• UDI-Public: 08714729784777
• 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: 12/06/2022

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: 07/14/2019
• Device Model Number: M0068502111
• Device Catalogue Number: 850-211
• Device Lot Number: 0000036932
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female