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 Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Injury (2348); Constipation (3274); Movement Disorder (4412); Unspecified Mental, Emotional or Behavioural Problem (4430); Fecal Incontinence (4571); Urinary Incontinence (4572)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

The event date was approximated to (b)(6) 2020, the bsc aware date, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an advantage fit system was implanted during a procedure performed on an unknown date.As reported by the patient's attorney, the patient has experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.

Manufacturer Narrative

Block b3: the event date was approximated to july 13, 2020, the bsc aware date, as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient code 2348 captures the reportable event of unknown injury.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: a1, b3, e1 (initial reporter country), and g2 have been corrected.A2, b2, b5, e4, h6, and h10 have been updated based on the additional information received on november 4, 2022.The country of event initially reported was united states.However, based on the additional information received on november 4, 2022, the implant facility information was provided.Upon further review, the implant facility, (b)(6) hospital is located in united kingdom.Therefore, the country of event was updated, and additional reports were submitted.Block b3: the event date was approximated to (b)(6) 2012, implant date, as the implant procedure date reported was 2012 and no event date was reported.Block e1: this event was reported by the patient's legal representation.The facility is: (b)(6).Block h6: patient code (b)(6) captures the reportable event of pain.Patient code (b)(6) captures the reportable event of fecal incontinence.Patient code (b)(6) captures the reportable event of unspecified mental, emotional or behavioral problem.Patient code (b)(6) captures the reportable event of urinary retention.Patient code (b)(6) captures the reportable event of urinary tract infection.Patient code (b)(6) captures the reportable event of movement disorder.Impact code f2303 captures the reportable event of medication required.Impact code f1202 captures the reportable event of disability.Impact code f12 has been used in the light of the patient sought legal recourse for a personal injury related to the device.

Event Description

It was reported that an advantage fit system was implanted during a procedure performed.As reported by the patient's attorney, the patient has experienced an unknown injury.The device is implanted and is not expected for analysis.Additional information received on (b)(6) 2022.The patient has explained how she had a tension-free vaginal tape (tvt) implanted at (b)(6) hospital in 2012.Initially the mesh helped but after a year or so the incontinence and pain got worse.Prior to this in 2011 she had a diagnosis of cin3 and a lletz.Followed by laparoscopic hysterectomy in (b)(6) 2012.In undated notes from the patient's physician, they were advised to continue with drug treatment under the care of the rheumatologists and urologists.Atorvastatin dose appropriate with ihd.They also discussed her other medications but she has had various discussions over the years e.G.Serotonin syndrome with tramadol and sertraline.The patient reported fecal incontinence and was discussing this with the urology nurse.She was not taking her macrogol or lactulose but has bought senna recently.The physician explained about adding fiber to her diet and only using the stimulants rarely as her bowel might get used to these and they become ineffective.The patient was under the care of the urologists for urinary incontinence.She reported severe incontinence problems especially at night when she uses two pads.Recently her solifenacin was increased to 10mg at night.She has the 5mg tablets but hasn't been taking them as she finds them ineffective.The physician advised her to take 2x5mg until she received the 10mg tablets.The physician also agreed to send her some information as she wanted to know how they worked and their side-effects.The physician suggested she monitored the side-effects and effectiveness of the solifenacin before and after taking them for comparison as she suffered from so many problems she could monitor any change.The patient was also experiencing reduced mobility and suffers from ra.She has tried many medications over the years including dmards.She received rituximab on (b)(6) 2021 and was due two more doses, the next being due (b)(6) 2022.She got pain including a stabbing pain around her right breast.She had a steroid injection last week and was taking prednisolone.She has been taking 10mg daily since august and reduced to 5mg daily after her steroid injection.However, she seemed to be reducing the dose down quite quickly.The physician advised her to continue on 5mg daily and then reduce slowly.Since she was complaining of fluid retention around her stomach, the physician asked her to monitor this as she reduced her steroids and to make an appointment with the doctor if it was still a problem after a couple of weeks on her reduced steroid dose.The patient was also prescribed with other medications which included aspirin 75mg dispersible, atorvastatin 80mg, clonazepam 2mg tablets, cyclizine 50mg tablets when required for nausea, fen bid forte 10% gel (advanz pharma).The patient was instructed to wash hands after using glyceryl trinitrate 400micrograms/dose pump sublingual spray.Lactulose 3.1-3.7g/5ml oral solution when required for constipation, macrogol compound oral powder sachets, omeprazole 20mg, paracetamol 500mg tablets when required for pain, pregabalin 150mg capsules, ramipril 1.25mg capsules, sertraline 100mg tablets, tramadol 50mg capsules as needed were also prescribed.On (b)(6) 2021, an email was received from the patient informing the physician that she has extreme incontinence problems even after she had the tvt mesh implanted in 2012.She was using two pads full flow at night, and she was still leaking.The patient mentioned that it was embarrassing and awful for her.She also worn pads during the day which was still wet but was no way as bad as at night.On (b)(6) , 2022, a letter was received by the patient from the healthcare facility regarding the patient's appointment for her pain management.They have discussed that the patient was terrified with the thought of removal of mesh and that the patient was worried that her body was not fit enough.The patient also reported that she was experiencing nocturia 3/4, urge (patient toilets every 2 hours as you lack urge sensations), the patient also double void and have incontinence using 4 pads per day, she was recommended intermittent self-catheterization but for some reason this did not happen, the patient also had urinary tract infections which rotates every 3 months between nitrofurantoin and trimethoprim.The patient was allergic to these 2 drugs.The patient tends towards constipation and were being seen by a gastroenterology consultant.The patient was using an enema once per week with good effect.In the physician's assessment, it would be helpful if the patient could refer back to her local gastro for her constipation.The patient's pain was situated in your lower back, abdomen, sides, legs -radiating down the front to her feet.Occasional shooting pains in her vagina was felt.She mobilized using sticks or wheelchair depending on the distance.She explained that she rarely went out.Pain medication included paracetamol, tramadol 100 mg tds, pregabalin 50 mg bd, cyclizine bd, clonazepam 2 mg twice daily, omeprazole, sertraline, and her heart medication.She noted that the pregabalin has increased her weight.She was 15 1/2 stone and 5 foot 9 inches tall.She was having regular infusions for her arthritis.The patient also suffered with fibromyalgia.Both of these conditions occurred after she had the mesh put in.She also had a myocardial infarction in (b)(6) 2018.On (b)(6) 2022, a letter was sent for patient referral.The patient's chief complaints were recurrent utis, chronic pain, and bladder problem.They have organized the patient for the following: physiotherapy assessment regarding musculoskeletal and pelvic floor management to look at the aspects of the incontinence as well as the pain.To have reviews with the pain management team regarding ongoing management of the pain and also to include physiotherapy for pain management.For continual support by the clinical psychology team.For annual review with the london complex mesh centre urogynaecology consultant.The physician have arranged a video urodynamic assessment as well as an mri of the pelvis and a proctogram.The former is to look at the type of incontinence she may have in the latter is to look at the mesh course as well as determine the type of prolapses that may be affecting her symptomatically.

• 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: 10393863
• MDR Text Key: 202694350
• Report Number: 3005099803-2020-03044
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

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 Model Number: M0068502110
• Device Catalogue Number: 850-211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 11/04/2022
• Supplement Dates FDA Received: 12/01/2022
• 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): Other; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female