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

Device Problem Positioning Problem (3009)

Patient Problems Erosion (1750); Inflammation (1932); Prolapse (2475); Dyspareunia (4505)

Event Date 01/25/2011

Event Type  Injury  

Manufacturer Narrative

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 the revision surgery.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 implanting and revision surgeon is (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that an advantage fit system was implanted during a tension free vaginal tape procedure performed on (b)(6) 2009, for the treatment of stress urinary incontinence, rectocele and cystocele.No old mesh could be seen or palpated.The procedure was completed with no patient complications and the patient was transferred to the recovery room in a stable condition.On (b)(6) 2011, the patient underwent mesh removal and mobilization of the vaginal mucosa procedures.Her preoperative and postoperative diagnosis include dyspareunia and mesh erosion.The patient was also noted to have a small cystocele and minimal rectocele.At approximately first third of the urethra, the vaginal mucosa had been eroded through.It had some granulation tissue and a foreign body reaction.Prolene mesh was noted.The physician grabbed the mesh with allis and gave some gentle traction and mobilized the vaginal mucosa that was just immediately over top of the part of the mesh that was coming through the skin.The mesh was then amputated.Because there was not a lot of blood supply to this area, the physician mobilized approximately 1.5 cm to the right and the left, along where the track of the mesh would have been.Some mesh was found and trimmed it.After palpation, no additional mesh was seen or felt.The physician noted that the mesh likely came from the original procedure that was done at a different hospital, secondary to the fact of the location of the mesh.It was located almost less than 1 cm away from the urethral opening which is not where the physician places mesh nor does the physician dissect up to that level.The physician noted his mesh was always place at the level of the middle third of the urethra, but this could not be 100% defined.

• 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; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15726014
• MDR Text Key: 303047803
• Report Number: 3005099803-2022-06463
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• 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: 10/13/2022
• 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; Other
• Patient Age: 54 YR
• Patient Sex: Female