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 Erosion (1750); Pain (1994); Scar Tissue (2060); Fibrosis (3167); Dyspareunia (4505)

Event Date 10/12/2017

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2017, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6).First revision surgery: dr.(b)(6).(b)(6) hospital.(b)(6).Second revision surgery: dr.(b)(6).(b)(6) medical center.(b)(6).Block h6: imdrf patient codes e2006, e1405, e2313, e1715 and e2330 capture the reportable events of mesh erosion, dyspareunia, scar tissue, sub urethral fibrosis, and pelvic pain.Imdrf impact codes f1905 and f1901 capture the reportable events of mesh excision surgeries and excision of excessive fibrosis.

Event Description

It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a transvaginal tape + advantage fit + cystoscopy procedure performed on (b)(6) 2017, for the treatment of stress urinary incontinence and hypermobile urethra.Findings included urethral opening was large and vaginal mucosa had poor integrity.The patient was taken to the recovery room in a stable condition.There were no complications.On (b)(6) 2022, the patient was diagnosed with sub urethral fibrosis, scar tissue and mesh erosion.She then underwent excision of mesh erosion and excessive fibrosis in the sub urethral area.The area below the urethra approximately a centimeter below the urethra demonstrated fibrotic area that was bothering the patient and her husband.A foley catheter was placed for clear visualization of the urethra, and possible mesh erosion, causing the scalp of this excessive fibrotic tissue to be approximately 2 x 1 cm.The area was grasped with an allis clamp and the elliptically excised in a horizontal fashion to allow for complete removal of the fibrotic material.The area was trimmed to make sure that there was no other fibrotic material or any mesh erosion then it was closed with a 2 mattress sutures to reapproximate the tissues.The patient tolerated the procedure well.On (b)(6) 2022, had another excision of the sling due to pelvic pain and exposed polypropylene mesh.The patient presented with complaints of pain during intercourse as well as exposed mid urethral sling.The sling was visualized and was excised with scissors up to the inferior ramus bilaterally.

• 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: 17586190
• MDR Text Key: 321561589
• Report Number: 3005099803-2023-04421
• 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
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2020
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: 0021006040
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female