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 Pain (1994); Scar Tissue (2060); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 02/28/2019

Event Type  Injury  

Manufacturer Narrative

Block e1: this event was reported by the patient's legal representation.The device was implanted by: (b)(6), md.(b)(6) hospital.Block h6: imdrf patient codes e1715, e2330 and e1405 capture the reportable events of scar tissue, pain and pain during intercourse.Imdrf impact code f1905 captures the reportable event of mesh excision.

Event Description

It was reported to boston scientific corporation that an advantage fit system was implanted into the patient during a mid-urethral sling procedure performed on (b)(6) 2019, for the treatment of urinary stress incontinence.During the procedure, after the sling was placed, the bladder was filled with 240ml irrigation fluid and the anesthesiologist made the patient valsalva against her endotracheal tube.With this test, it was noted that the patient had clear large-volume stress incontinence shooting urine at least 3 feet out of her urethra.The sling was tightened and the valsalva maneuver repeated; the physician ended up tightening the sling 6 times until her stress incontinence was small-volume.The physician did not want to tighten it further for fear of getting it too tight.The procedure was completed with no complications.The patient reported that her sling never resolved her urinary incontinence.She stated that the sling did not help her.She also has pain in the vaginal area, pelvic pain, bladder pain and has painful intercourse.On (b)(6) 2023, the patient underwent excision of suburethral portion of the mesh and cystoscopy due to stress urinary incontinence, possible erosion of vaginal mesh and pain in the vaginal and bladder area.Examination under anesthesia revealed what felt like scar tissue but there was not any obvious mesh noted or felt.The area was explored further to make sure there was nothing abnormal about it.Furthermore, during the procedure, a bleeder was noted on the right side of urethra which was controlled with a vicryl suture.No further bleeding was identified.The procedure was completed.The patient was examined in the recovery room and appeared to be comfortable.

• 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: 17738625
• MDR Text Key: 323311916
• Report Number: 3005099803-2023-04796
• 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: 09/13/2023

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 Expiration Date: 03/15/2021
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: 0021870804
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female