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); Inflammation (1932)
Date of Event	08/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: date of event was approximated to (b)(6) 2017, implant date, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).First revision surgery: dr.(b)(6).Second revision surgery: dr.(b)(6).Block h6: imdrf patient codes e2006 and e2326 capture the reportable events of mesh eroded in the colon and inflamed and indurated tissue.Imdrf impact code f1905 captures the reportable events of two mesh excision surgeries.
Event or Problem Description
It was reported to boston scientific corporation that an advantage system device was implanted into the patient during a suspension sling urethra with tvt procedure performed on (b)(6) 2017, for the treatment of urinary incontinence.The procedure was completed with no complications.The patient tolerated the procedure well and was taken to recovery in stable condition.On (b)(6) 2021, the patient underwent surgical intervention due to eroded bladder mesh in the colon.The eroded mesh was noted in the sigmoid colon with tenting of the mucosa.The mesh was carefully cut with an endoscopic scissors without injuring the colon mucosa.A small piece was retrieved with a forceps.The patient tolerated the procedure well and was transferred to recovery in stable condition.On (b)(6) 2021, the patient had another surgery of mesh excision due to inflamed and indurated tissue.Exam under anesthesia showed midline exposure of sling mesh for approximately 1cm that was central.There was no fornices erosion.This was a very difficult place to access due to body dystocia.A self-retaining retractor was placed to maximize exposure.It was difficult to decide how to approach because the tissue was so indurated; however, after evaluation the surgical planes, it was decided to make a transverse incision over the sling which was done.The mesh was skeletonized into each fornices and divided it with scissors.It was then submitted to pathology.The patient went to the recovery room in satisfactory condition.

• 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17585608
• Report Number: 3005099803-2023-04416
• Device Sequence Number: 3626575
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 08/21/2023

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 Model Number: M0068502000
• Device Catalogue Number: 850-200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 57 YR
• Patient Sex: Female