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

Model Number	M0068502120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Micturition Urgency (1871); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency / Polyuria (2275); Deformity/ Disfigurement (2360); Obstruction/Occlusion (2422); Dysuria (2684); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Urinary Incontinence (4572)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of march december 11, 2023 was chosen as a best estimate based on the date of the mesh removal.Block e1: this event was reported by the patient's legal representation.The implant and mesh removal surgeons are: (b)(6).Block h6: the following imdrf patient codes capture the reportable events below: e2328 - bladder outlet obstruction, e1310 - urinary tract infection, e1301 - dysuria, e2330 - pain, e2308 - disfigurement.The following imdrf impact codes capture the reportable events below: f1905 - mesh removal surgery, f2301 - self-catheterization to address bladder outlet obstruction.
Event or Problem Description
It was reported that the patient underwent implantation of an advantage fit system and has since experienced multiple injuries, including constipation, bladder outlet obstruction necessitating self-catheterization, urinary tract infection, urinary urgency and frequency, urge incontinence, and dysuria.Subsequently, she underwent mesh removal on (b)(6) 2023.Despite this, the patient has suffered significant pain, disfigurement, embarrassment, and financial loss due to unnecessary expenses and lost wages.She may require additional surgery and ongoing treatment.The patient has sustained and will continue to sustain severe and debilitating injuries, serious bodily harm, and mental and physical pain and suffering, with economic losses expected to continue far into the future.
Additional Manufacturer Narrative
Block h2: additional information - blocks a2: date of birth, b5, d6b, h6: patient codes and h6: impact codes.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2023 was chosen as a best estimate based on the date of the mesh removal.Block e1: this event was reported by the patient's legal representation.The implant and mesh removal surgeons are: implanting physician: (b)(6) md.(b)(6) hospital.(b)(6).Mesh removal surgeon ((b)(6) 2023).(b)(6) md.(b)(6) hospital.(b)(6).Block h6: the following imdrf patient codes capture the reportable events below: e2328 - bladder outlet obstruction.E1310 - urinary tract infection.E1301 - dysuria.E2330 - pain.E2308 - disfigurement.E1715 - scar tissue.E1309 - incomplete bladder emptying.The following imdrf impact codes capture the reportable events below: f1903 - mesh removal surgery.F2301 - self-catheterization to address bladder outlet obstruction.
Event or Problem Description
It was reported that the patient underwent implantation of an advantage fit system as part of a total vaginal hysterectomy with bilateral salpingo-oophorectomy, paravaginal defect repair with graft, posterior colporrhaphy with graft, enterocele repair, uterosacral ligament suspension, mid-urethral sling, and cystoscopy.A non-boston scientific graft was implanted concomitantly.Pre- and postoperative diagnoses included rectocele and stress urinary incontinence.Intraoperative complications included an enlarged, cystic left ovary.Following implantation, the patient experienced multiple injuries, including constipation, bladder outlet obstruction necessitating self-catheterization, urinary tract infection, urinary urgency and frequency, urge incontinence, and dysuria.Subsequently, on (b)(6) 2023, the patient underwent removal of the sling due to bladder outlet obstruction and incomplete bladder emptying.The sling was located via scar tissue near the urethra, freed from surrounding tissue on both sides, and removed.Post-removal cystoscopy confirmed no injuries.Despite sling removal, the patient continues to experience significant pain, disfigurement, embarrassment, and financial loss due to unnecessary expenses and lost wages.She may require additional surgery and ongoing treatment.The patient has sustained and will continue to sustain severe and debilitating injuries, serious bodily harm, and mental and physical pain and suffering, with economic losses expected to continue far into the future.
Event or Problem Description
It was reported that the patient underwent implantation of an advantage fit system as part of a total vaginal hysterectomy with bilateral salpingo-oophorectomy, paravaginal defect repair with graft, posterior colporrhaphy with graft, enterocele repair, uterosacral ligament suspension, mid-urethral sling, and cystoscopy.A non-boston scientific graft was implanted concomitantly.Pre- and postoperative diagnoses included rectocele and stress urinary incontinence.Intraoperative complications included an enlarged, cystic left ovary.Following implantation, the patient experienced multiple injuries, including constipation, bladder outlet obstruction necessitating self-catheterization, urinary tract infection, urinary urgency and frequency, urge incontinence, and dysuria.Subsequently, on (b)(6) 2023, the patient underwent removal of the sling due to bladder outlet obstruction and incomplete bladder emptying.The sling was located via scar tissue near the urethra, freed from surrounding tissue on both sides, and removed.Post-removal cystoscopy confirmed no injuries.Pathologic evaluation of the excised material reported a final diagnosis of vaginal sling mesh, excision, composed of fibrous tissue with foreign body material.Gross examination described a 1.1 x 0.5 x 0.2 cm aggregate of tan-pink soft tissue.Despite sling removal, the patient continues to experience significant pain, disfigurement, embarrassment, and financial loss due to unnecessary expenses and lost wages.She may require additional surgery and ongoing treatment.The patient has sustained and will continue to sustain severe and debilitating injuries, serious bodily harm, and mental and physical pain and suffering, with economic losses expected to continue far into the future.
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of march december 11, 2023 was chosen as a best estimate based on the date of the mesh removal.Block e1: this event was reported by the patient's legal representation.The implant and mesh removal surgeons are: implanting physician: (b)(6).Mesh removal surgeon (b)(6) 2023) (b)(6).Block h6: the following imdrf patient codes capture the reportable events below: e2328 - bladder outlet obstruction, e1310 - urinary tract infection, e1301 - dysuria, e2330 - pain, e2308 - disfigurement, e1715 - scar tissue, e1309 - incomplete bladder emptying.The following imdrf impact codes capture the reportable events below: f1903 - mesh removal surgery f2301 - self-catheterization to address bladder outlet obstruction block h11: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.The reported patient symptoms are known risks associated with this device type and indicated as such in the instructions for use.

• Brand Name: ADVANTAGE FIT? BLUE SYSTEM
• Common Device Name: 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: 22366466
• Report Number: 2124215-2025-42913
• Device Sequence Number: 21228147
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: (01)08714729961925(17)240808(10)27806946
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2024
• Device Model Number: M0068502120
• Device Catalogue Number: M0068502120
• Device Lot Number: 0027806946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 10/03/2025; 03/19/2026
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 10/31/2025; 04/16/2026
• Date Device Manufactured: 08/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female