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

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

Patient Problems Erosion (1750); Fatigue (1849); Micturition Urgency (1871); Pain (1994); Urinary Frequency (2275); Prolapse (2475); Constipation (3274); Urinary Incontinence (4572)

Event Date 08/23/2011

Event Type  Injury  

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) 2011.It was reported that the patient began to have pelvic pain three or years later.On (b)(6) 2018, the patient underwent a first stage removal of tension-free vaginal tape.On (b)(6) 2022, the patient was reviewed in the outpatient setting with the following complaints: vaginal prolapse, foreign body in the vagina (tvt in situ), and bladder problems.The patient had her video urodynamic studies done, and in the physician's assessment, she is suitable for a colposuspension and paravaginal repair.The physician and patient have discussed the options of the different types of surgery, and given the findings of her urodynamic assessment, the most suitable is the one they have agreed to.The patient mentioned that she had spoken to women who had colposuspension done in the past and was told it was done with mesh, but the physician has reassured her that it is done with stitching rather than mesh.The patient had also been told that women who have colposuspension and paravaginal repair get hernias, but per the physician, this is the case in patients who have had traditionally laparoscopic mesh removal or in whom the bmi is very elevated, and they really resulted in finding radiated bladders, which are both surgically correctable.The patient also requested that when they do the operation, they do a cervical smear, which they were happy to accommodate.The patient is also concerned about having a perineal deficiency, so following the colposuspension and paravaginal repair, as well as the removal of the tvt mesh arms, they will inspect the vagina and repair any laxity or deficiency of the posterior vaginal wall or perineum.She claims to have felt something snap on her abdomen.A small defect or hernia may occur from time to time, which can be examined during surgery.Moreover, the patient is happy with this plan of action, and the physician will let the team know that she is ready to go for surgery.The patient's clinical history, past surgical and medical histories were evaluated on (b)(6) 2022.According to the report, the patient had imaging on (b)(6) 2018, which revealed that the tape, which was placed at the distal urethra, was lying flat and not eroding.On (b)(6) 2019, the patient additionally underwent a video cystometrogram, with the following results: normal compliance and sensation with no evidence of disorder.Moderate stress urinary incontinence demonstrated with 10ml league and type 2b bladder neck descent.Void was unobstructed with unremarkable radiographs and no evidence of reflux.On (b)(6) 2022, the patient was reviewed in the outpatient setting presenting the following symptoms: chronic pain, fatigue down her spine, legs, in her abdomen, pain in vagina.Daily stress incontinence, some urgency and urge incontinence.The patient wears pads and need to be change 9 to 15 per day.Nocturia 1-2 times; urinary frequency; no difficulties in passing urine.Some prolapse symptoms.Constipation.Episode of rectal bleeding.

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 (b)(6) 2011 was chosen as a best estimate based on the date of mesh was implanted.The complainant was unable to provide the suspect device lot number and upn; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The physicians are: (b)(6).(b)(4).

• Brand Name: ADVANTAGE 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: 15923539
• MDR Text Key: 304877924
• Report Number: 3005099803-2022-07200
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2022
• 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 Sex: Female