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

Model Number M0068502111

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

Patient Problems Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Deformity/ Disfigurement (2360); Depression (2361); Obstruction/Occlusion (2422); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)

Event Date 02/07/2017

Event Type  Injury  

Manufacturer Narrative

Block b3: date of event was approximated to (b)(6), 2017, the implant date, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: the following imdrf patient codes capture the reportable events of: e2330: pain.E2308: disfigurement.E1906: infection.E1405: dyspareunia.E2401: other injuries, damages and suffering.E1401: vaginal discharge.E0206: mental anguish.The following imdrf impact codes capture the reportable events of: f19: multiple corrective surgeries.F1202: disability.F1204: permanent injury.

Event Description

It was reported to boston scientific corporation that an advantage fit mid-urethral sling system device was implanted into the patient during a transvaginal surgery performed on (b)(6), 2017.As reported by the patient's attorney, the patient has experienced severe emotional pain and injury and has suffered and will suffer apprehension of increased risk for injuries, infections, pain, mental anguish, discharge, and multiple corrective surgeries, significant pain, disfigurement and harm, severe and debilitating injuries, serious bodily injury, mental and physical pain and suffering, has sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedures, obligations for medical services, and other damages.As a direct and proximate result of the implant, patient has been injured, and sustained severe and permanent pain, suffering, disability, impairment, and loss of enjoyment of life, loss of the enjoyment of sexual relations.Patient's injuries and damages are permanent and will continue into the future.She may have to undergo additional surgery in the future and may continue to suffer significant pain, unnecessary medical expense for medical care, treatment and therapies long into the future.

Manufacturer Narrative

Block b3: date of event was approximated to (b)(6) 2017, the implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).The revising physician is: dr.(b)(6) block h6: the following imdrf patient codes capture the reportable events of: e2330: pain, e2308: disfigurement, e1906: infection, e1405: dyspareunia, e2401: other injuries, damages and suffering, e1401: vaginal discharge, e0206: mental anguish, e020202: depression, e2328: bladder obstruction.The following imdrf impact codes capture the reportable events of: f19: multiple corrective surgeries, f1202: disability, f1204: permanent injury, f1905: revision of sling.

Event Description

It was reported to boston scientific corporation that an advantage fit mid-urethral sling system device was implanted into the patient during a transvaginal surgery performed on (b)(6) 2017.As reported by the patient's attorney, the patient has experienced severe emotional pain and injury and has suffered and will suffer apprehension of increased risk for injuries, infections, pain, mental anguish, discharge, and multiple corrective surgeries, significant pain, disfigurement and harm, severe and debilitating injuries, serious bodily injury, mental and physical pain and suffering, has sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedures, obligations for medical services, and other damages.As a direct and proximate result of the implant, patient has been injured, and sustained severe and permanent pain, suffering, disability, impairment, and loss of enjoyment of life, loss of the enjoyment of sexual relations.Patient's injuries and damages are permanent and will continue into the future.She may have to undergo additional surgery in the future and may continue to suffer significant pain, unnecessary medical expense for medical care, treatment and therapies long into the future.Additional information received on january 3, 2024.On (b)(6) 2017, the patient underwent a mid-urethral sling procedure using advantage fit and a cystoscopy for the treatment of stress urinary incontinence and urethral hypermobility.The procedure went well, with no injury to the bladder or urethra.The patient was then sent to the post-anesthesia care unit in stable condition with a foley catheter in place.However, after the procedure, the patient experienced bladder outlet obstruction and pain.Therefore, on (b)(6) 2021, the patient underwent a revision of the sling, transvaginal removal of foreign material, cystoscopy, and urethral dilation.During the procedure, a dissection was carried out in the midline to free the sling.The sling was located near the distal end of the urethra, and a full-thickness incision was made in the sling to relieve obstruction.Lateral attachments were left undisturbed.The vaginal incision was closed with a 2-0 vicryl suture, and an estrogen cream-impregnated vaginal packing was placed.Cystoscopy demonstrated good support of the urethra, with no foreign material inside the urinary tract.The urethra was serially dilated to 33 french caliber.The ureters appeared patent, with clear efflux.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 18012497
• MDR Text Key: 326676317
• Report Number: 2124215-2023-58459
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729784777
• UDI-Public: 08714729784777
• 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,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2019
• Device Model Number: M0068502111
• Device Catalogue Number: 850-211
• Device Lot Number: 0000045399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2016
• 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: 55 YR
• Patient Sex: Female