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); Hemorrhage/Bleeding (1888); Dyspareunia (4505)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2017, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: imdrf patient codes e2006, e1405 and e0506 capture the reportable events of erosion of surgical mesh into the vagina, dyspareunia and postmenopausal vaginal bleeding.Imdrf impact code f1905 captures the reportable event of mesh excision surgery.

Event Description

It was reported to boston scientific corporation that an advantage system was implanted into the patient during a laparoscopic sacral colpopexy, cystocele repair + laparoscopic enterocele repair + retropubic midurethral sling using a boston scientific advantage system + cystoscopy procedure performed on (b)(6) 2017, for the treatment of prolapse of vaginal vault after hysteroscopy, lateral cystocele vaginal enterocele, rectocele, stress incontinence, stage 2 anterior vaginal wall prolapse, stage 2 posterior vaginal wall prolapse and stage 2 vaginal vault prolapse.The patient tolerated the procedure well.On (b)(6) 2022, the patient underwent excision of exposed surgical mesh and vaginal repair due to erosion of surgical mesh into the vagina.The patient presented with postmenopausal vaginal bleeding and dyspareunia.Pelvic exam revealed a 1cm area of exposed surgical mesh at the right apex corner of the vaginal cuff.There was an approximately 1cm linear area of mesh erosion into right side of the vaginal cuff at the apex.Only the portion of the exposed mesh was excised.The patient was woken up from anesthesia in stable condition.She will start vaginal estrogen therapy after discharge and follow up in one week.

• 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: 17539066
• MDR Text Key: 321048821
• Report Number: 3005099803-2023-04277
• 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: 08/14/2023

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: 08/17/2020
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: 0021027392
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2017
• 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
• Patient Race: White