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

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

Patient Problems Erosion (1750); Unspecified Infection (1930)

Event Date 11/04/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage system device was used during an advantage fit urethral sling and cystocele repair procedure performed on (b)(6) 2013.After the procedure, when the patient went downstairs, she had a strong valsalva spasm, felt a contraction, and started to bleed vaginally.The patient was found to have an entire cystocele and vaginal mucosa that had been torn open.The wound was then closed, and the patient tolerated the procedure well.Lastly, the patient had a cystoscopy, cystocele repair, and an advantage fit urethral sling.The patient was sent to the recovery room in stable condition.On (b)(6) 2022, the patient underwent an open right groin exploration, laparoscopic appendectomy, laparoscopic mesh explantation, and laparoscopic colon repair due to an infected foreign body granuloma of the right inguinal canal and urethral sling foreign body erosion into the colon (colon injury).During the procedure, no hernia was seen.Instead, a round ligament was identified and inflamed.A granuloma was seen medial to the round ligament.A decision was made to convert to laparoscopic exploration.Additionally, when adhesiolysis was carried out to dissect the cecum away from the abdominal wall, a mesh was discovered to have been eroded into the colon lumen through a hole in the colon.The mesh was then retracted pulled free of the abdominal wall and removed.The patient tolerated the procedure well, and she was transferred to the recovery room in stable condition.

Manufacturer Narrative

The exact event onset date is unknown.The provided event date of (b)(6) 2022, was chosen as the best estimate based on the revision date.Imdrf patient code e2006 captures the reportable event of foreign body erosion.Imdrf impact code e1906 captures the reportable event of infected foreign body granuloma.Imdrf impact code f1903 captures the reportable event of mesh explantation.

• 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
• MDR Report Key: 19076128
• MDR Text Key: 339774172
• Report Number: 2124215-2024-19138
• 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: 04/09/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 44 YR
• Patient Sex: Female