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 Pain (1994); Urinary Retention (2119); Prolapse (2475)

Event Date 04/04/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage system device was implanted during a lateral cystocele repair, midline cystocele repair, rectocele repair, vaginal enterocele repair, perineocele repair, prude-vaginal sling placement on the posterior wall, cystoscopy, repair of urethrocele, bilateral trigger point injection of the pelvic floor muscles, and bilateral pudendal nerve injection procedure performed on (b)(6) 2019, for the treatment of lateral cystocele, midline cystocele, rectocele, vaginal enterocele, perineocele, urethrocele, and stress urinary incontinence.The patient tolerated the procedure well and was carried to the recovery room in good condition.The patient was diagnosed with uterovaginal prolapse, cystocele, rectocele, pelvic pain, and dysfunctional voiding.She then underwent a robotic hysterectomy supracervical with tubes, sacrocolpopexy with y mesh, robotic cystocele repair with paravaginal defect, removal of the bladder neck sling with complex urethroplasty, and cystoscopy on (b)(6) 2023.During the procedure, the mid-urethral sling was found to be under a great amount of tension distal to the urethra and was very deeply placed.Metzenbaum scissors were used to dissect behind the sling so that they could be able to transect the sling at the midline.The sling arms were dissected out laterally and send for pathology.No additional mesh was palpated transvaginally.Cystoscopy confirmed there were no lesions at the end of the procedure.There were no further patient complications reported.

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(4) 2023, was chosen as the best estimate based on the date of the removal of bladder neck sling with complex urethroplasty.Block d4, h4: the complainant was unable to provide the suspect device upn and 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 implanting physician is: dr.(b)(6).Block h6: imdrf patient code e2333 captures the reportable event of uterovaginal prolapse, cystocele and rectocele.Imdrf patient code e2330 captures the reportable event of vaginal pain.Imdrf patient code e1309 captures the reportable event of dysfunctional voiding.Imdrf impact code f1901 captures the reportable event of robotic cystocele repair.Imdrf impact code f1903 captures the reportable event of removal of bladder neck sling with complex urethroplasty.

• 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: 17766866
• MDR Text Key: 323643191
• Report Number: 3005099803-2023-04987
• 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: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• 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: 08/31/2023
• 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: 55 YR
• Patient Sex: Female