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

Model Number M0068502110

Device Problem Defective Device (2588)

Patient Problems Adhesion(s) (1695); Erosion (1750); Pain (1994); Scar Tissue (2060); Urinary Frequency (2275); Obstruction/Occlusion (2422); Prolapse (2475); Dysuria (2684)

Event Date 12/11/2014

Event Type  Injury  

Manufacturer Narrative

There was no information available regarding the event date.Therefore, it was approximated to (b)(6) 2014, the implant date has been selected.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The revision surgeon is: (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that an advantage fit system was implanted during a transvaginal tape, cystocele repair, and cystourethroscopy procedure performed on (b)(6) 2014.The patient's diagnoses were voiding difficulty, stress incontinence, and pelvic prolapse with cystocele formation.The options have been explained to the patient, and she elected to undergo the above-mentioned procedure.It was noted that the dissection was somewhat tedious because of previous surgery and scarring.Since the procedure, the patient had worsening pain and prolapse.The patient presented with pelvic pain, a feeling of a bulge, and a splinting to urinate.She described squatting to void, frequency, and nocturia.Urodynamics were performed and showed large capacity, there was no stress urinary incontinence, and there could be possible obstructed detrusor pressures with void.Her exam in the office did reveal stage 2 prolapse and what was thought to be mesh fibers.She desired to proceed with appropriate surgical repairs.On (b)(6) 2017, the patient underwent vaginal vault suspension with uterosacral ligament suspension, lysis of adhesions, enterocele repair with internal mccall's, take down of previous sling, anterior repair, cystourethroscopy, rectocele repair, and perineorrhaphy for the preoperative diagnoses of pelvic organ prolapse, cystocele, rectocele, enterocele, vaginal vault prolapse, urinary obstruction (difficulty with urination), and pelvic pain.She had operative findings included stage 2 pelvic organ prolapse, pelvic adhesions with bowel adhered over the right uterosacral ligament, eroded mesh (mesh fibers eroded through her vaginal mucosa), the sling had migrated to the bladder neck, and the patient had dense and scarred tissue.Dissection was very difficult because of her prior surgeries.The tissue was thickened and scarred, and tissue planes were difficult to identify.The sling was sharply dissected off the urethra and bladder using mayo scissors and traction.The dissection was carried out nearly to the inferior pubic rami.A significant portion of the sling was taken down, leaving only the lateral arms within the patient.The mesh that was removed was sent for pathology.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15459137
• MDR Text Key: 300300162
• Report Number: 3005099803-2022-05362
• 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: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: ML00002814
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2015
• 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): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Race: White