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); Scar Tissue (2060)

Event Date 04/02/2015

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage fit system was used during a total laparoscopic hysterectomy, bilateral salpingectomy, and tension-free vaginal tape and cystoscopy procedures performed on (b)(6) 2014 to treat a patient with abnormal uterine bleeding, uterine leiomyoma and stress urinary incontinence.During the patient's post operative visit, a two centimeter area of vaginal mesh erosion from transvaginal vaginal tape was visualized on pelvic exam.The patient was treated conservatively but management failed and the patient was counseled on surgical removal of this exposed mesh.On (b)(6) 2015, a vaginal mesh removal and cystoscopy procedures were performed.The patient was administered with ancef 2g iv prior to skin incision.The patient was taken to the operating room, where she was placed under general endotracheal anesthesia without difficulty.The patient was then prepped and draped in a normal sterile fashion in dorsal lithotomy position in a neurovascularly safe manner.Attention was then turned towards the perineum, where the physician inserted a posterior weighted speculum.Two right angle retractors were then placed in order to visualize the exposed mesh.The bladder was then in-and-out catheterized with 150 ml of clear urine.At this point, the vaginal mesh was able to be visualized.It was approximately 2.5 cm in length.The physician was able to slide a pair of debakey pick-ups behind the vaginal mesh and picked it up from the underlying vaginal epithelium with ease.At this point, a metzenbaum scissors was used to dissect along the vaginal epithelium underneath the vaginal mesh superiorly and laterally into the vagina apex.Once the physician was able to undermine this tissue, the physician then cut the mesh initially on the patient's left side as high as safety could be accomplished.The mesh was then cut again on the right side.Approximately three centimeters of mesh was removed.At this point, the physician trimmed the edges of the vaginal epithelium until they were fresh with no scar tissue and active bleeding was noted from the edges.Inspecting the area of the problem, it was noted to come together under no tension best when approximated from superior to inferior as opposed to side-to-side.At this point, the urethra was inspected and noted to be without any evidence of injury with the red rubber catheter inserted.The physician then closed the vaginal epithelium in an interrupted fashion with multiple sutures of #2-0 polysorb.These were all placed and then placed hemostasis, then again inspected this area to make sure there were no injury to the underlying urethra.These sutures were then all tied down and at this point, the red rubber catheter was removed and a 70 degree cystoscope was placed into the bladder.The bladder was filled with 300 ml of normal saline.The urethra was inspected carefully, both up on entry to the bladder and upon exit, and there was no evidence of any injury to the urethra or any suture material within the urethra.The bladder itself was intact with no evidence of injury.The lateral edges of the bladder mucosa were inspected carefully to make sure there was no evidence of any mesh erosion through the bladder mucosa and there was none noted.Once the bladder had been inspected carefully and there was no evidence of any injury or mesh erosion and also no urethral injury, the cystoscope was removed.The bladder was drained.At this point, the vaginal sutures were then cut.The vaginal closure was then irrigated with a dilute solution of bacitracin and gentamicin.The suture line was noted to be hemostatic and at this point, the patient was awakened from general anesthesia and taken to the recovery room in good condition.

Manufacturer Narrative

Date of event was approximated to (b)(6) 2021, implant date, as no event date was reported.The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.This event was reported by the patient's legal representation.The implant and revision procedure surgeon is: (b)(6).

• 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: 15416682
• MDR Text Key: 299834703
• Report Number: 3005099803-2022-05049
• 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: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female