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

Model Number 73189

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

Patient Problems Erosion (1750); Pain (1994); Prolapse (2475); Dyspareunia (4505); Fecal Incontinence (4571)

Event Date 04/13/2022

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of may 11, 2022, was chosen as a best estimate based on the date of mesh removal.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6) at (b)(6) hospital.Phone:(b)(6).The revision physician is: dr.(b)(6).Phone: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2006 - mesh erosion.E2330 - pain.E1405 - painful intercourse.The following imdrf impact codes capture the reportable events of: f1905 - vaginal mesh removal.

Event Description

It was reported to boston scientific that an advantage fit system was implanted into the patient during a laparoscopic hysterectomy, bilateral salpingectomy, paravaginal defect repair with graft, posterior colporrhaphy with graft, enterocele repair, uterosacral ligament suspension, mid-urethral sling, and cystoscopy procedures performed on (b)(6) 2019, for the treatment of uterine prolapse, bilateral paravaginal defects, enterocele, rectocele, and stress urinary incontinence.Description of procedure: the colpotomy was then begun anteriorly.This was continued until the cervix was completely separated from the vagina.The uterus cervix, and tubes, were then pulled into the vagina, and then removed.Attention was then turned to the vaginal portion of the procedure.The enterocele was closed reefing the peritoneum from uterosacral ligament on the right to uterosacral ligament on the left.The vaginal cuff was closed horizontally.Attention was turned to the vaginal paravaginal defect pair.After injection with dilute vasopressin solution, a vertical incision was made the anterior vagina from the cuff to the bladder neck.Weakness and absence of fascia was noted.Skin incisions of five millimeters were then suprapubically, two centimeters to the and left of midline.Cystoscopy was performed; the urethra, trigone, and ureteral orifices were normal in appearance.There was no damage to the bladder.Strong jets of urine were seen from the ureteral orifices bilaterally.The mesh was trimmed below skin level.Skin incisions were closed using dermabond glue.The vagina closed using 2-0 vicryl suture in a running stitch.Weakness and absence of the rectovaginal fascia were noted throughout this repair.The graft was cut to fit the space and was attached proximally at the vaginal apex, laterally at the pelvic sidewall, distally at the perineal.Rectal exam showed excellent closure of the defect and no damage too.The vagina was closed using 2-0 vicryl suture.Second look laparoscopy was performed, and excellent hemostasis noted.The cuff was irrigated copiously.The pneumoperitoneum was reversed.The fascia closed on all ports using 0-vicryl suture.The skin closed using stitches and skin glue.She was transferred in a stable condition.On (b)(6) 2022, the patient was diagnosed with mesh erosion, rectocele, enterocele, and fecal incontinence and underwent sling revision, posterior repair, enterocele repair, and cystourethroscopy.The patient reports pain with intercourse of her and her partner, and mesh exposure was identified by her physician.The exposed mesh was trimmed in the office, but pain persisted.The patient desired definitive management with sling revision.Treatments including risks and benefits were discussed.All questions were answered.Sling revision: there was no evidence of injury to the urethra or the bladder.A midline incision was made to dissect the mesh from the left sulus; however, the mesh could be seen folded over in the midline and then extending inferolateral back to the right side.The vaginal epithelium trimmed.Normal genital hiatus was identified in terms of the width, consequently, a transverse incision was made in order to avoid narrowing the introitus.This was followed by midline vertical incision which extended several centimeters from the apex.The vaginal epithelium was dissected off the underlying vagina mucsularis bilaterally.A 2-0 vicryl was used to reduce the enterocele sac with a purse string suture.Minimal vaginal epithelium trimmed and 2-0 vicryl used to close the vaginal opening in running fashion.The transverse incision was closed with interrupted sutures in order to avoid narrowing the introitus.Repeat cystourethroscopy was performed and there as no evidence of any injury to the urethra or bladder with bilateral jets identified.The vagina was then copiously irrigated and repeat rectal exam was performed.There was no evidence of rectal injury.The patient had tolerated the procedure well and was taken to recovery.

• Brand Name: ADVANTAGE FIT BLUE 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18749355
• MDR Text Key: 335934091
• Report Number: 2124215-2024-09852
• Device Sequence Number: 1
• Product Code: OTN
• 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: 02/21/2024

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: 06/05/2022
• Device Model Number: 73189
• Device Catalogue Number: 73189
• Device Lot Number: 0023910317
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• 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): Other; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female