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

Model Number M0068502000

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

Patient Problems Erosion (1750); Incontinence (1928); Urinary Retention (2119); Injury (2348); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 01/31/2008

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2008 (implant date) as no event date was reported.This complaint was reported by the patient's lawyer.The device was implanted at (b)(6) by dr.(b)(6).(b)(4).The complainant indicated that the device is not available for return; 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 system was implanted into the patient on (b)(6) 2008.As reported by the patient's attorney, the patient underwent a revision surgery on (b)(6) 2013 due to stress incontinence and failed sling.Synthetic sling identified and freed segment over the urethra was removed and was sent for histopathology.On (b)(6) 2013, the patient underwent another revision surgery due to obstructive voiding.On (b)(6) 2104, the patient underwent a revision surgery due to urge incontinence.On (b)(6) 2017, the patient underwent cystoscopy with biopsy of bladder procedure due to obstructive lower urinary tract symptoms and incomplete bladder emptying.Upon vaginal examination, sling erosion was noted on the right anterior vaginal wall with some sling eroding out.Part of the sling that eroded was excised.On (b)(6) 2017, she had another revision surgery due to sling erosion and voiding dysfunction.On (b)(6) 2017, patient underwent cystoscopy with urethroscopy procedure due to an obstructive sub-urethral sling.

• 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): 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: 11135448
• MDR Text Key: 225753186
• Report Number: 3005099803-2020-06596
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 01/07/2021

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: 05/31/2010
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: 0ML7051001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR