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); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987); Scar Tissue (2060); Urinary Tract Infection (2120); Dyspareunia (4505); Fecal Incontinence (4571); Urinary Incontinence (4572)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

This event was reported by the patient's legal representation.Implanting physician: (b)(6).Vaginal mesh erosion repair surgeon: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that the patient was diagnosed with stress urinary incontinence with extensive condylomata.On (b)(6) 2013, she was implanted with an advantage fit system device during tension-free vaginal tape, cystoscopy, and laser vaporization of condylomata.During the implant procedure, cystoscopy showed that the device needle had pierced the bladder.The device was then removed and replaced with good placement.The tvt mesh was then approximated to the suburethral area using a kelly clamp as a spacer.After the procedure, the patient was taken to the recovery room in satisfactory condition.On (b)(6) 2020, the patient presented with complaints of feeling a foreign body in her vagina since around the time of her sling procedure in 2013.Reportedly, it has not been bothersome until it has started causing discomfort and bleeding with intercourse.Additionally, the patient reported leakage of urine associated with urgency as well as fecal incontinence which has gotten worse.She was also assessed with having urinary tract infection symptoms.On (b)(6) 2021, the patient underwent vaginal mesh erosion repair and cystocopy - spinal procedures due to erosion of bladder suspension mesh, sequela.During the procedure, the mesh was divided in the midline and followed out laterally.On cystoscopy, the bladder epithelium was grossly normal but there was an indentation at the bladder dome that could be indicative of mesh in the detrusor.There was a 2 cm exposed piece of colorless suburethral mesh consistent with a midurethral sling at the midurethra.There was also epithelialization deep to the exposed mesh and a small buttock skin tag at 3:00 from the anus that the patient had previously requested be excised.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12373156
• MDR Text Key: 268324172
• Report Number: 3005099803-2021-04254
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2021

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
• Device Expiration Date: 05/31/2016
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: ML00001522
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR