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

Device Problem Material Integrity Problem (2978)

Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Fistula (1862); Flatus (1865); Hemorrhage/Bleeding (1888); Inflammation (1932); Abnormal Vaginal Discharge (2123); Stenosis (2263); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 01/01/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage fit system and an upsylon y mesh were implanted during a laparoscopic lysis of adhesions, sacro colpopexy, mid urethral sling and cystourethroscopy procedure performed on (b)(6) 2019, for the treatment of symptomatic uterovaginal prolapse and symptomatic mixed urinary incontinence.The patient had a history of inflammation and diverticular abscess.Additionally, the patient alleged discharge from her vagina and some gas passing with her urine.After a cystoscopy, a colo-vesicle fistula was suspected.In 2021, a colonoscopy showed diverticular disease with mild structuring.The patient present sling erosion and migration leading to an exploratory laparoscopy converted to exploratory laparotomy, small bowel fistula resection, small bowel anastomosis, excision of bladder sling mesh, sigmoid colectomy, takedown of the splenic flexure, colorectal anastomosis and cystoscopy procedure on (b)(6) 2022.During procedure, the colon was identified on the left pelvic sidewall; therefore, a finger dissection of the structures was performed.A diverticular abscess and a small amount of purulent material was drained.Careful blunt dissection was performed to free the colon from the pelvic sidewall and extended down towards the pelvis.In the pelvis there was an additional area of severe inflammatory changes with small bowel densely adherent to the bladder and the pelvis.The colon also appeared to be involved in these inflammatory changes.Gentle blunt dissection was performed as well as sharp dissection with scissors.It was noted that there was a piece of small bowel that was so adherent to the bladder that was required to excise this piece of small bowel.This was performed with sharp excisional debridement using metzenbaum scissors.After the small bowel was released from the bladder, a piece of the sling was recognized underneath the small bowel and entrapped around.The mesh was adhered to the sacrum or the retroperitoneum in the pelvis as well as to the small bowel.The segment was freed, liberating about 15 to 20 cm of small bowel that was involved in the inflammatory process.With this excision most of the bladder mesh was also removed.With the bladder mesh in the small bowel completely removed from the pelvis, it was observed that there were still inflammatory changes of the colon down into the pelvis where the bladder mesh had eroded either around the colon or the inflammatory changes of the bladder mesh, bladder and small bowel had created considerable inflammatory changes on the colon itself.To repair the small bowel, there was resection of the area with the fistula.Cystoscopy was performed an no additional damage was noted in the bladder.The patient tolerated the procedure with no known complication.The patient was stable and discharged to post-anesthesia care unit.

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2021, was chosen as the best estimate based on the first-time patient symptoms was noted after implant.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).Block h6: imdrf patient code e2006 captures the reportable event of eroded bladder sling.Imdrf patient code e172001 captures the reportable event of diverticular disease with diverticular abscess.Imdrf patient code e2101 captures the reportable event of adhesions.Imdrf patient code e2314 captures the reportable event of fistula.Imdrf patient code e2337 captures the reportable event of stenosis.Imdrf patient code e2326 captures the reportable event of inflammatory changes.Imdrf patient code e1401 captures the reportable event of vaginal discharge.Imdrf patient code e1011 captures the reportable event of flatus.Imdrf impact code f1905 captures the reportable event of excision of bladder sling mesh.Imdrf patient code e0506 captures the reportable event of hemorrhage.Imdrf patient code e2338 captures the reportable event of edema.Imdrf impact code f1901 captures the reportable event of additional surgery.Imdrf impact code f2202 captures the reportable event of endoscopic procedure.

• 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 18055535
• MDR Text Key: 327163488
• Report Number: 3005099803-2023-05791
• 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: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2023
• 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
• Patient Age: 75 YR
• Patient Sex: Female