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

Model Number	M0068502000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Calcium Deposits/Calcification (1758); Hemorrhage/Blood Loss/Bleeding (1888); Vaginal Mucosa Damage (2124)
Date of Event	09/03/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: date of event was approximated to (b)(6) 2014, the implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Revision surgery: (b)(6) block h6: imdrf patient codes e2006, e1519, e0506 and e230901 capture the reportable events of exposure of mesh within the urethra, anterior vaginal wall polyps, vaginal spotting, and calcification.Imdrf impact codes f1905 and f1901 capture the reportable events of mesh excision and excision of anterior vaginal wall polyps.
Event or Problem Description
It was reported to boston scientific corporation that an advantage system device was implanted into the patient during a tvt procedure performed on (b)(4) 2014, for the treatment of stress urinary incontinence.The procedure was completed with no complications.The patient was taken to the recovery room in stable condition.On (b)(6) 2023, the patient presented with bothersome vaginal spotting from a polypoid mass of the vagina.She had to undergo excision of anterior vaginal wall polyps and removal of exposed urethral mesh.Findings showed a polypoid friable soft polyp originating from the anterior mid urethra.There was a dimpling of the vaginal mucosa at this location.Cystoscopy now reveals exposure of mesh within the urethra, and this was partially calcified.During the procedure, an elliptical incision was created sharply around the dimpled portion of the urethra including the polypoid mass.The mass and vaginal mucosa were sent as a specimen.Mesh was excised and sent for specimen.The physician did not continue to work to remove the entire mesh.The patient tolerated the procedure well and there were no complications or implants.

• Brand Name: ADVANTAGE SYSTEM
• Common Device Name: 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: 17772237
• Report Number: 3005099803-2023-04986
• Device Sequence Number: 15209314
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: ML00002274
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female