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

Model Number M0068502110

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

Patient Problems Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Vaginal Mucosa Damage (2124); Stenosis (2263); Prolapse (2475); Dyspareunia (4505)

Event Date 02/06/2018

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage fit system was implanted into the patient during a removal of mirena intrauterine device dilatation and curettage with frozen section + hysterectomy total laparoscopic + bilateral salpingectomy + anterior posterior repair + bladder suspension transvaginal tape insertion + cystoscopy procedure performed on (b)(6) 2018 for the treatment of prolapse, 2nd degree uterine prolapse, 2nd degree cystocele, 1st degree rectocele, urethro-vesicular junction hypermobility, atypical glandular cells on pap smear of cervix and endometriosis.Findings showed uterus sounded to 8cm and endometrial curetting (frozen section) was benign.The patient tolerated the procedure well and went to recovery in stable condition.On (b)(6) 2019, the patient was diagnosed with perineal laxity and anterior vaginal polyp.Findings also included large 1st degree rectocele.The patient then underwent dissection of vaginal mucosa.The vaginal mucosa was dissected away from the rectum both bluntly and sharply.The rectovaginal fascia was plicated with interrupted sutures of 2-0 polysorb.The excess vaginal mucosa was trimmed and then closed with a 0-polysorb suture, including the perineum.On (b)(6) 2023, she had advantage sling removal, urethral lysis, and removal of abdominal mesh due to vaginal pain, pelvic pain, incomplete bladder emptying, pain with coitus and urinary stricture.This was a very difficult surgery due to the right and left sling arms being very deep in the obturator muscles, especially the right sling that was also adherent to the right pelvic sidewall.The left sling as in the obturator muscles and bladder wall.The sling was at the bladder base cephalad to the bladder neck.The advantage sling was identified at the bladder base.The mesh was dissected free and was incised in the midline and dissected as far as lateral as possible.A urethral lysis was performed with sharp dissection to further free the urethra and scar tissue.There was bleeding noted and secured the muscle veins with cautery.Floseal and gelfoam was placed to the right and left of the bladder next to the obturator muscles.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2018, 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).(b)(6) hospital (b)(6).Revision surgery: dr.(b)(6).(b)(6) hospital (b)(6).Block h6: imdrf patient codes e2101, e2330, e1309, e1405, e1519, e2337, e1715, and e0506 capture the reportable events of adhesions, pain, urinary retention, dyspareunia, polyp, urinary stricture, scar tissue, and bleeding which required floseal and gelfoam.Imdrf impact codes f1903 and f1901 capture the reportable events of mesh explantation, and urethral lysis to further free the urethra and scar tissue and muscle veins were secured with cautery due to bleeding.

• Brand Name: ADVANTAGE FIT 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: 17594502
• MDR Text Key: 321626190
• Report Number: 3005099803-2023-04428
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• 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: 08/22/2023

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: 11/07/2020
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: 0021357604
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female