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

Model Number M0068502110

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Pain (1994); Scar Tissue (2060); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2020, the date of the vaginal mesh removal, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Initial reporter: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).The revision surgeon is: dr.(b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an advantage fit system was used during a retropubic mid-urethral sling (advantage fit) and cystoscopy procedure performed on (b)(6) 2020.The patient had symptomatic stress urinary incontinence and desired surgical management.On exam under anesthesia, the patient had stage ii prolapse consistent with what was observed in the office.Cystoscopy revealed a normal bladder with the patient's ureters bilaterally and with a normal urethra.The bladder remained intact throughout, and the sling could be seen rolling appropriately behind the urothelium.On (b)(6) 2020, the patient underwent vaginal sling revision, urethrolysis, kelly plication, laparoscopic tension-free vaginal tape (tvt) mesh removal, laparoscopic burch, suprapubic catheter placement, cystoscopy, and exparel injection.The patient had right and left lower quadrant pain, pelvic pain, dyspareunia, vaginal mesh extrusion, and stress urinary incontinence.The patient came in with these chief complaints and felt that her condition was severe enough to warrant surgical correction.After giving her informed consent, she elected to undergo the said procedures.Under anesthesia, it was noticed that the patient had vaginal mesh extrusion through the vaginal epithelium on the patient's left side of the urethra and a cording and tightness of the mesh on both the right and left side.In the office, examination revealed that the patient had vaginal pain in the periurethral area as well as the left and right pubic areas and the left and right lower quadrants.At this time, the mesh was dissected all the way to the pubocervical fascia bilaterally, and then incised and cut the mesh at its insertion point into the pubocervical fascia on each side of the urethra.At this point, urethrolysis has been performed.Due to all the scar tissue in this area, the mesh was mobilized away from the vaginal epithelium, the underlying urethra, and the periurethral tissue.Additionally, because of the bleeding in this area, hemostatic sutures were done, and the sutures were used to elevate the suburethral area using 2-0 vicryl in a mattress fashion.At this time, the vaginal epithelium was closed with 2-0 vicryl suture, and attention was turned towards the abdomen and the laparoscopic approach.At this point in time, an open laparoscopy was done with 3 of the ports placed under direct visualization.Then, the bowel of the cul-de-sac was mobilized, retrograde filled the bladder, and then entered the space of retzius between the obliterated umbilical ligaments, 2 cm anterior to the vesicoperitoneal reflection.In the space of retzius, the insertion points of the mesh into the anterior abdominal wall were identified.The cooper's ligament was mobilized off first and forced all the way anteriorly to the anterior abdominal wall, and tension was placed on the arms going into the anterior abdominal wall until the mesh was cut out of the anterior abdominal wall bilaterally.There was no mesh left in the anterior abdominal wall.Then they dissected all the way down to the pubocervical fascia and cut the mesh at the pubocervical fascia.Currently, the complete mesh was removed, and a laparoscopic burch procedure was done next.Using cv2 gore-tex suture in a figure-of-eight fashion, 2 sutures were placed on each side of the urethra through the pubocervical fascia in a figure-of-eight fashion, one at the mid urethra, and one at the urethrovesical junction up to the ipsilateral cooper's ligament.This elevated and made a hammock for the suburethral area.Moreover, the area hemostatic was made, placed some floseal, and closed the vesicoperitoneal reflection with 0 monocryl suture.At this point, a cystoscopy was performed with no evidence of exudate, diverticulum, or malignancy.There was no evidence of needle penetration or trauma to the bladder or urethral mucosa.Bilateral ureteral patency was confirmed.Furthermore, a suprapubic catheter placement was done, both with a cystoscopic and a laparoscopic view.It was observed as it entered the dome of the bladder.Once it did, the introducer was pulled out, then they removed the guidewire first, and then blew up the foley balloon in the dome of the bladder.And then, it was retracted on the foley bulb into the dome of the bladder and found the area was hemostatic.Reportedly, the port sites were closed in a normal fashion after removing the ports.Finally, the patient's vagina was packed, and she was sent to the recovery room in a stable condition.

• 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: 14760879
• MDR Text Key: 295029458
• Report Number: 3005099803-2022-03373
• 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: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• 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: 05/25/2022
• 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: 56 YR
• Patient Sex: Female