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); Fistula (1862)
Date of Event	04/25/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advantage system device was implanted into the patient during a transvaginal tape placement procedure performed on (b)(6) 2012, for the treatment of stress incontinence.No complications were observed during the procedure, and the patient was transferred to the recovery room in stable condition.The patient underwent a biopsy on (b)(6) 2022, to address a bothersome mass in her urethra resulting from a urethral diverticulum.Despite inconclusive imaging, examination in the clinic revealed purulent discharge and mass compression.The patient opted for surgical exploration to confirm the suspected diagnosis.During the examination, the doctor noticed a larger and firmer mass on the side of the urethra.This mass had shifted towards the right from its previous position in the middle.Trying to compress the mass did not reveal any functions, and there was no sign of pus in the mass or urethra.Moreover, a fistula had developed between the urethra and vagina since the last check-up.The opening of the fistula was about 1-2 cm higher than the urethral meatus, and the mucosa was highly friable.To confirm the fistula, a 19 french cystoscope was inserted into the urethra.The doctor thoroughly examined the bladder but found no abnormalities.During the pullback, it was confirmed that the patient had a urethral vaginal fistula.Moreover, the patient tolerated the procedure well.On (b)(6) 2022, the patient underwent a partial excision of the tension-free vaginal tape, urethrovaginal fistula repair with placement of martius flap, harvesting of martius labial flap from the left labia, and cystoscopy with suprapubic catheter placement due to eroded tension-free vaginal tape with urethrovaginal fistula.During the procedure, the sling was clamped on both sides, then divided in the middle and some adherent tissue was released from each side of the sling.The physician aimed to preserve some of the lateral attachment of the sling on each side to help with future continence.After that, the sling was excised on both sides, removing approximately 2 cm of it.Following that, the physician inspected the tissues of the fistula and found some not-so-healthy-looking tissue that needed to be excised.The fistula was then closed transversely by reapproximating the proximal to distal edges using continuous 4-0 monocryl.In addition, the patient tolerated the procedure well.
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2012, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).(b)(6) med center.(b)(6).The explanting physician is: dr.(b)(6).(b)(6) hospital.(b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2006 - has been used to capture the reported event of eroded tension-free vaginal tape.E2314 - has been used to capture the reported event of urethrovaginal fistula.The following imdrf impact codes capture the reportable events of: f1905 - has been used to capture the reported event of vaginal mesh excision.

• 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: 17659425
• Report Number: 3005099803-2023-04660
• Device Sequence Number: 6993838
• 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: 2012
• 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): 08/31/2023

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: 01/31/2015
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: ML00000486
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2012
• 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: 45 YR
• Patient Sex: Female