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

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

Patient Problems Adhesion(s) (1695); Prolapse (2475); Urinary Incontinence (4572)

Event Date 04/07/2008

Event Type  Injury  

Event Description

This manufacturer report pertains to one of two devices used on the same patient.It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling system and an advantage system were used during an endoscopic bladder neck suspension with transabdominal mesh placement procedure performed on (b)(6) 2008 for the treatment of stress urinary incontinence.As reported by the patient's attorney, the patient experienced recurrent cystocele and stress urinary incontinence post procedure.On (b)(6) 2016, the patient underwent a robotic-assisted burch urethropexy, anterior colporrhaphy and mesh revision procedure.During the procedure, exam revealed a stage 2 prolapse.There was a large amount of omental adhesions to anterior wall on the right side all the way to the midline.During the anterior repair and mesh revision, the previous sling was identified and was carefully dissected from its surrounding periurethral tissues.Initially just the left and right portions were removed, however, the mesh remnant suburethral was determined to cause discomfort at the kelly plication.Thus, the suburethral mesh at midline was also removed.When performing burch urethropexy, there was difficulty with dissection due to the previous sling that was released from suprapubic area.Finally, cystoscopy revealed no trauma, suture or mesh in the bladder or urethra and bilateral ureteral efflux was visualized at the end of the case.

Manufacturer Narrative

Date of event is approximated to (b)(6) 2008, implant date, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.Implanting surgeon: dr.(b)(6).Revision surgeon: dr.(b)(6).(b)(4).

• 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15573570
• MDR Text Key: 301493013
• Report Number: 3005099803-2022-05734
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female