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

Model Number M0068502110

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

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Obstruction/Occlusion (2422)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(6), 2022, was chosen as a best estimate based on the date of the revision surgery.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: imdrf patient code e2006 captures the reportable event of erosion of bladder suspension mesh.Imdrf patient code e230901 captures the reportable event of calcified sling.Imdrf patient code e230901 captures the reportable event of bladder stone.Imdrf impact codes f1905 capture the reportable events of excision of mesh calcification and associated bladder stone.

Event Description

It was reported to boston scientific corporation that an advantage fit system device was implanted during an examination under anesthesia and a tension-free vaginal tape procedure using an advantage kit with cystoscopic guidance.The procedure was performed on (b)(6) 2018, for the treatment of stress urinary incontinence.The patient had a history of stress urinary incontinence following a retropubic mid-urethral sling placement in 2017 and was complicated by mesh erosion at the level of the bladder neck and near the urethral orifices.On (b)(6), 2022, the patient underwent an exploratory laparotomy, transvesical excision of intravesical portion of eroded mid-urethral mesh, excision of mesh calcification and associated bladder stone, bilateral 5f ureteral catheter placement and removal and foley catheter placement (18f latex).The patient tolerated the procedure well with no complications.

• Brand Name: ADVANTAGE FIT 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17720883
• MDR Text Key: 323098397
• Report Number: 3005099803-2023-04836
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• 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: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2021
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: 0021762753
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female