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

Model Number 850-211

Device Problem Positioning Problem (3009)

Patient Problems Erosion (1750); Micturition Urgency (1871); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Discomfort (2330); Unspecified Tissue Injury (4559); Urinary Incontinence (4572)

Event Date 11/01/2013

Event Type  Injury  

Event Description

Note: this report pertains to one of two devices used for the same patient.Refer to manufacturer report # 3005099803-2022-07089 for the associated device information.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) 2013 for recurrent urinary incontinence following an initial advantage fit system device implant in 2006.It was documented in her operation notes for the second procedure that when the advantage tvt was placed on the right side there was kinking of the bladder wall and, therefore, it was removed and re-inserted and at that time, the cystoscopy was normal and no further kinking on the right side.The left side tape was placed without complication.Following the second advantage implant, she had an unsuccessful trial without catheter and required re-insertion of a catheter.She was reviewed in (b)(6) 2013 and all was well, but she represented in (b)(6) 2013 with discomfort in her right groin and a hard ridge in her vagina with no dyspareunia.She needed to double void to empty her bladder at this time with a slow stream.On examination, she had a palpable ridge of her tape to the right and less to the left.It was explained to her at the time that it was the tape that she felt and offered to have it divided with the risk of recurrence of her incontinence and at that time she decided not to have further surgery.She was advised to continue with topical estrogen.She also had pain on the right-hand side with urgency, but she drank a lot of tea.On examination she had a clear tender ridge and bowed tape on the right side which was extremely tender to touch.She was given some vagifem and advice about her fluid intake.In a urogynecology multidisciplinary team meeting in 2020, it was suggested that patient should undergo removal or excision of the bowed area of tape.However, it was decided not to remove the tape but inject the area with steroids.On (b)(6) 2020, patient had intramuscular injection of vitamin b12.On (b)(6) 2020 urinalysis and culture revealed an e.Coli urinary tract infection.On (b)(6) 2020, the patient was seen in gynecology clinic and underwent ultrasonography.The physician explained that following the menopause, vaginal tissues often become atrophic and thinner, increasing the likelihood of symptoms from tvt.Suggested to try vagifem every night for two weeks and then reduce to twice weekly.On (b)(6) 2020, patient had increasing urinary urgency, not sexually active and not currently on hormone replacement therapy.There was a clear tender area on the right side over a bowed tvt tape which felt very tight.The vaginal mucosa was also atrophic and appeared thinner at this area.On (b)(6) 2020, on speculum examination, there was no tape erosion; however, on digital examination the tape was found superficially at the very top on the right side and was very tender on palpation.Patient was suggested to remove only the portion of the mesh on the right side of the urethra, since there was no tenderness on palpation on the left side.She agreed and was keen to proceed with the procedure.In an email on (b)(6) 2020, patient mentioned that a physician had already removed a few parts of the mesh.She was told to have a removal surgery which was scheduled as urgent procedure but was advised steroid injections first would be best due to high risks on damaging other organs to which the patient eventually agreed.The patient was then given the injections and moved/tucked up the tape.On november 4, 2020, it was stated in the letter that local anesthetic injection had not helped at all and patient was keen on tape removal.In a telephone on (b)(6) 2021, patient was making progress having the tvt tape removed, however, she was told that she was discharged from the service.She was wondering where to go next if the facility would not see her.On (b)(6) 2021, the patient was also having neuropathic type pain on the right side.On (b)(6) 2021, mri for pelvis results showed the tape was identified bilaterally at the level of the anterior abdominal wall.The proximal intra pelvic portion extended inferiorly towards the bladder base but beyond this the tape was not clearly visualized.Normal retropubic space.There is no focal abnormality, collection or oedema in the expected line of the tape.Limited views of the tvt tape.No cause for unilateral right-sided vaginal pain visualized.On (b)(6) 2022, it was stated in a letter that the patient had vaginal exposure of the tape along with urinary leakage.Required investigations include urodynamics and a flexible cystoscopy.

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2013 was chosen as a best estimate based on the date the symptoms first noted.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(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; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15894121
• MDR Text Key: 304606945
• Report Number: 3005099803-2022-07091
• 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: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 850-211
• 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: 49 YR
• Patient Sex: Female