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); Pain (1994); Urinary Tract Infection (2120); Discomfort (2330); Disability (2371)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

The lot number: 0000041745 does not provide a match in the system search, therefore, the device manufacture, and expiration dates cannot be determined.Other: tga adverse incident report reference no: (b)(4); submitted to tga (therapeutic goods administration) by the user.(b)(4).The complaint device is not expected to be returned for evaluation, therefore, a failure 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 an advantage fit system device was implanted into the patient during a hysterectomy procedure performed on (b)(6) 2017.According to the patient, first six months after the placement, it was a lot of pain across the pelvis.The patient also experienced groin pain, pain behind knees, buttocks and legs.The patient had seven utis in eight months, and unable to walk more than ten minutes without pain increasing.The patient had experienced a lot of cramping.It was painful to sit and could not lie on the sides for four months as it caused pain like it was pulling on the sling.The patient underwent 3d scan and it showed the sling eroded into the urethra, and it was close to the vaginal wall.It was also discovered that the sling was placed in a peculiar way horizontally and too tight.Subsequently, the patient was scheduled for the removal of the device on (b)(6) 2017, and would probably need another operation to address the incontinence with a fascial sling.Boston scientific has been unable to gather additional information regarding the event to date.

• 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: 10890632
• MDR Text Key: 218586555
• Report Number: 3005099803-2020-05652
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• Combination Product (y/n): N
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 11/23/2020

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 Model Number: M0068502110
• Device Catalogue Number: 850-211
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 11/24/2020
• 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): Other