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 Erosion (1750); Inflammation (1932); Pain (1994); Scar Tissue (2060); Dyspareunia (4505)

Event Date 06/21/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage fit system device was implanted during a total vaginal hysterectomy (tvh), sacrospinous ligament suspension, posterior colporrhaphy, perineorrhaphy, retropubic tension-free vaginal tape (tvt), and cystoscopy procedure performed on (b)(6) 2021, for the treatment of grade 2 uterine prolapse, grade 3 posterior compartment prolapse, stage ii anterior broad compartment prolapse, urethral hypermobility, and stress urinary incontinence.During the procedure, the sling was identified as there was mesh exposure on the right side.The mesh was incised in the midline and dissected as far as possible.Urethral lysis was performed with a sharp dissection to free the urethra and scar tissue.The sling arms were freed from the underlying sub-urethral tissues and the obturator muscles; however, it was noted that the procedure was difficult due to the left arm sling being deep in the obturator muscles.The sling mesh ends were held with a clamp while an incision was made down to the level of the fascia.The mesh was identified and dissected free.The sling arms were scarred to the pubic bone; therefore, progressive dissection was needed to mobilize the sling arms from the bone to the obturator muscles and be completely freed.The explanted mesh was sent for analysis.The laboratory report noted the material had surrounding giant cells and mild chronic inflammation.No malignancy was identified.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2022, was chosen as the best estimate based on the date of the advantage sling removal and removal of abdominal mesh.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: imdrf patient code e2330 captures the reportable event of vaginal, pelvic and groin pain.Imdrf patient code e1405 captures the reportable event of pain with coitus.Imdrf patient code e2006 captures the reportable event of mesh exposure.Imdrf patient code e1715 captures the reportable event of scarred arms to the pubic bone.Imdrf patient code e1715 captures the reportable event of mild chronic inflammation.Imdrf impact code f1901 captures the reportable event of urethral lysis.Imdrf impact code f1903 captures the reportable event of advantage sling removal ad removal of abdominal mesh.

• 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: 17772796
• MDR Text Key: 323714321
• Report Number: 3005099803-2023-04974
• 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: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2023
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: 0026481918
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female