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); Unspecified Infection (1930); Laceration(s) (1946); Pain (1994); Discomfort (2330); Obstruction/Occlusion (2422)

Event Date 06/21/2021

Event Type  Injury  

Manufacturer Narrative

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).Assistants: dr.(b)(6).Dr.(b)(6).Dr.(b)(6).Surgeon for revision surgery: dr.(b)(6).(b)(6) medical center.(b)(4) nm.Block h6: imdrf patient codes e2006, e2328, e2009, e2311, e1906 and e2330 capture the reportable events of bladder erosion, bladder stone, right labia tear, discomfort, infection and pain.Imdrf impact codes f23 and f1905 capture the reportable events of right labia tear repair and removal of excess mesh.

Event Description

It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a retropubic mid-urethral sling + cystoscopic injection of 150 unit on botulinum toxin a into the bladder procedure performed on (b)(6) 2021, due to stress urinary incontinence with low-pressure urethra and urgency incontinence with past inadequate response to 100u botox.Findings revealed that there was extensive cystitis cystica (less than 40 lesions) throughout the bladder.Moderate trabeculations and 3 wide-mouthed (less than 2 cm) diverticula between trabeculations.The trigone had normal metaplasia.Bilateral urethral orifices were seen to be jetting urine.The urethra on withdrawal of the cystoscope had normal mucosa with no foreign material or injury.During the implant, there were 3 tears in the right labia minora due to retraction, and these were repaired with a figure of eight sutures of 2-0 vicryl.The patient tolerated the procedure well and was returned to the post anesthesia care unit in stable condition.Shortly thereafter the sling placement, the patient was having a lot of pain and discomfort.She also started developing recurrent infections in the urine.On (b)(6) 2022, the patient was diagnosed with bladder stone and bladder erosion of the implanted mesh.She then underwent cystolitholapaxy.Using the laser, the physician was able to remove some of the excess mesh, but it was evident that the mesh was completely embedded into the bladder neck and would be dangerous to continue lasering.No specimen was sent to pathology, but multiple stones were removed.The patient was awakened from anesthesia and taken to the recovery room in excellent condition.Further discussion of plans of care, likely the best option for this patient would be to do an open removal or robotic removal of the vaginal mesh in the bladder.If the mesh is not removed, she will continue to have bladder stone formation as well as infections and other issues such as pain.

• 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: 17425797
• MDR Text Key: 320067989
• Report Number: 3005099803-2023-04003
• 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: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2023
• 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: 57 YR
• Patient Sex: Female