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

Model Number 850-211

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

Patient Problems Erosion (1750); Pain (1994); Dyspareunia (4505)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2016 was chosen as a best estimate based on the date of the revision surgery.Initial reporter: this event was reported by the patient's legal representation.The implanting surgeon is dr.(b)(6).The revision surgeon is dr.(b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that an advantage fit system was implanted during a total vaginal hysterectomy, uterosacral ligament suspension, anterior and posterior colpoperineorrhaphy, and mid-urethral sling and cystoscopy procedures performed on (b)(6) 2015 for the treatment of stage three uterovaginal prolapse and stress urinary incontinence.The patient tolerated the procedure well and was taken to post-anesthesia care unit in stable condition.On (b)(6) 2016, the patient underwent removal of exposed mid urethral sling mesh and cystourethroscopy procedures.Her preoperative and postoperative diagnosis include mid urethral mesh extrusion, vaginal pain, and dyspareunia.The exposed mid urethral sling mesh was palpated at the midline and was approximately 0.5 centimeter was felt.An incision next to the exposure was made and the urethral mucosa was undermined with metzenbaum scissors.The exposed mesh was excised without the intention of removing the entire sling as it was effectively helping her with her stress incontinence.Cystourethroscopy was performed and was normal without masses, polyps, mesh, foreign bodies in the bladder or the urethra.The bladder was drained and the scope was removed.The procedure was completed without complications and the patient was taken to the recovery room in stable condition.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15949957
• MDR Text Key: 305158360
• Report Number: 3005099803-2022-07022
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729784777
• 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: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 850-211
• Device Catalogue Number: 850-211
• Device Lot Number: ML00002951
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2015
• 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; Other
• Patient Age: 56 YR
• Patient Sex: Female