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 Inflammation (1932); Pain (1994); Scar Tissue (2060); Fibrosis (3167); Urethral Stenosis/Stricture (4501); Dyspareunia (4505)

Event Date 11/12/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2021, sling removal date, as no event date was reported.Initial reporter name and address: this event was reported by the patient's legal representation.The implanting surgeon is: dr.(b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a patient was implanted with an advantage fit system device on (b)(6) 2019 during a midurethral sling placement, anterior and posterior cortical perineorrhaphy, vaginal enterocele repair and cystourethroscopy procedure for the treatment of stress urinary incontinence with urethral hypermobility, cystocele, rectocele and enterocele.According to the complainant, the patient experienced vaginal pain, pelvic pain, and pain during sexual intercourse after the procedure.It was not reported when the onset of symptoms had started.On (b)(6) 2021 the patient underwent a surgery to remove the sling, urethral lysis and anterior colporrhapy.The procedure was described to be a very difficult surgery due to the right sling arm being deep in the obturator muscles as well as the left arm in the obturator muscle.The left arm was scarred to the pubic bone and the sling was at the bladder neck/bladder and was under tension.Urethral lysis was performed to free the urethra and scar tissue.The procedure was completed without complications.

Manufacturer Narrative

Correction: blocks b5 and h6 patient codes.Block b3: date of event was approximated to november 12, 2021, sling removal date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: dr.(b)(6) (b)(6) hospital.Block h6: patient code e2330 captures the reportable event of vaginal pain and pelvic pain, patient code e1405 captures the reportable event of coital pain, impact code f1903 captures the reportable event of sling removal surgery.

Event Description

It was reported to boston scientific corporation that a patient was implanted with an advantage fit system device on (b)(6), 2019 during a midurethral sling placement, anterior and posterior cortical perineorrhaphy, vaginal enterocele repair and cystourethroscopy procedure for the treatment of stress urinary incontinence with urethral hypermobility, cystocele, rectocele and enterocele.According to the complainant, the patient experienced vaginal pain, pelvic pain, and pain during sexual intercourse after the procedure.It was not reported when the onset of symptoms had started.On (b)(6) 2021, the patient underwent a surgery to remove the sling, urethral lysis and anterior colporrhaphy.Urinary stricture was noted during the procedure.The procedure was described to be a very difficult surgery due to the right sling arm being deep in the obturator muscles as well as the left arm in the obturator muscle.The left arm was scarred to the pubic bone and the sling was at the bladder neck/bladder and was under tension.Urethral lysis was performed to free the urethra and scar tissue.The procedure was completed without complications.Pathology of the excised sling noted mesh with surrounding fibrosis, chronic inflammation, and focal foreign body giant cell reaction.

• 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: 15465011
• MDR Text Key: 300386904
• Report Number: 3005099803-2022-05319
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2022
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: 0023904248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 10/11/2022
• Supplement Dates FDA Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female