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

Model Number M0068502000

Device Problem Material Deformation (2976)

Patient Problems Adhesion(s) (1695); Erosion (1750); Pain (1994); Perforation (2001); Dysuria (2684); Dyspareunia (4505)

Event Date 07/10/2019

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage system was implanted during a sling placement, hysterectomy, and cystoscopy procedure performed on (b)(6) 2019, for the treatment of stress urinary incontinence.According to the findings, there was some blood in the bladder prior to proceeding with the sling procedure, however, the physician thought that this was from the dissection of the bladder during the hysterectomy, though on cystoscopy there was no distinct injury noted.After the device was placed, cystoscopy showed 2-3 mm of blue mesh material on the left side.The sling was pulled back on the left side and replaced.Subsequent cystoscopy showed no blue mesh material seen, though there was slight hematuria.At the end of the sling procedure, the urine was clear, and the vagina appeared normal at the end of the case.On (b)(6) 2021, the patient underwent cystourethroscopy with bilateral ureterolysis and mesh sling removal for the treatment of urethral pain, dysuria, dyspareunia, and mesh erosion.During the cystourethroscopy, it was revealed that there were normal bladder and urethral findings.A cystourethroscopy had been done in clinic as well, which revealed no mesh in the bladder or the urethra.Attention was then turned to the anterior wall of the vagina.After the infiltration of the anterior wall of the vagina, a u incision was made with the use of a knife.A careful sharp dissection of the underlying vaginal wall from the underlying urethra and bladder was performed.The mesh was identified.Bilateral urethrolysis was carefully performed after mobilizing the sling from the midline position where it was seen to be quite adherent to the urethra and folded over.This was mobilized and then transected in the midline.Careful bilateral urethrolysis was performed of the periurethral adhesions to the sling, and the lateral periurethral adhesions to the sling.This was accomplished bilaterally.With the use of the mayo scissors, the mesh sling was removed bilaterally.This was sent for permanent pathology.Copious irrigation was performed, and hemostasis was achieved with bovie as well as with surgiflo.The periurethral connective tissue was plicated with 2 interrupted 3-0 vicryl sutures, and the vaginal epithelium was reclosed after trimming with interrupted 2-0 vicryl sutures.The bladder was in and out catheterized.A vaginal pack was placed.The patient was placed in the supine position, extubated in the operating room, taken to the recovery room in stable condition with stable vital signs, having tolerated the procedure well.

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2019, the date the sling was implanted, as no event date was reported.This event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).(b)(4).The removed mesh 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.

• 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: 15107077
• MDR Text Key: 296651218
• Report Number: 3005099803-2022-04055
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2022

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: 11/07/2021
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: 0022910595
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female