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); Urinary Retention (2119); Prolapse (2475); Urinary Incontinence (4572)

Event Date 07/10/2015

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2015, the date the sling was implanted, 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 excised mesh 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 implanted during a laparoscopic enterolysis freeing of intestinal adhesions, a laparoscopic total hysterectomy, bilateral salpingectomy, laparoscopic abdominal sacral colpopexy using a non-bsc mesh, an advantage fit sling implantation (no tension sling), cystoscopy, and left ureteral catheter placement procedure performed on (b)(6) 2015, for the treatment of uterine prolapse, cystocele, stress urinary incontinence, hypermobile urethra, and pelvic adhesive disease.On (b)(6) 2021, the patient underwent laparoscopic uterosacral ligament suspension; excision of eroded urethral mesh from the urethral lumen (transecting the urethra lumen); complicated urethral repair; operative cystoscopy with coaptite urethral bulking; anterior colporrhaphy and posterior colporrhaphy for the treatment of recurrent vaginal vault prolapse, cystocele, rectocele, incomplete bladder emptying/urinary retention; stress urinary incontinence; and erosion of prior retropubic sling mesh into the urethral lumen.The patient was taken to the operating room where she was placed under general anesthesia.A foley catheter was placed into the patient's bladder.It was difficult to place due to the mesh obstructing the urethral meatus.Approximately 5 mm from the meatus, apically it was able to be inserted.The urethral meatus was grasped with an allis clamp and elevated.An incision was noted approximately 5 mm from the meatus and was indenting into the urethra.The incision was opened in an inverted u-shaped manner, to be later closed in a vest-over-pants manner.The epithelium was dissected free distally.The area of the mesh that was indenting into the urethra was grasped with a kocher clamp and the mesh was dissected out laterally to the pubic bone.It was then dissected into the urethra at the posterior portion of the urethra in order to excise the mesh from the urethra, which it had grown into and through a portion of the urethral urothelium, which was also excised with the mesh.This was all sent to pathology.A cystoscopy revealed no further evidence of urethral mesh or foreign bodies.The urethral lumen was intact.A laparoscopic uterosacral ligament suspension was performed.The 5-mm laparoscope was placed directly into the patient's abdomen.The abdomen was insufflated with carbon dioxide gas.A suprapubic 5-mm port, and right and left lateral 5-mm ports were placed under direct visualization.The bowel was mobilized into the upper abdomen.She was found to have a piece of mesh from the right apex of the vagina to the sacral promontory.A normal right ovary and a normal appendix were noted.She had minimal scar tissue noted.She still had a mild cystocele and rectocele.The decision was made to proceed with a laparoscopic uterosacral ligament suspension, which needed to re-suspend the apex uniformly across the apex.The bladder was dissected free from the anterior vaginal wall using the eea sizer in the vagina, being careful not to touch the urethral incision.The uterosacral ligaments were identified.The ureters were identified.Anterior colporrhaphy, operative cystoscopy, and coaptite urethral bulking were performed.Once the cystocele was completely reduced, the vaginal epithelium was minimally trimmed and repaired using 2-0 monocryl.The foley catheter was removed.The 0-degree cystoscope was placed transurethrally.She was found to have no evidence of ureteral or bladder injury.She had vigorous efflux of pyridium-stained urine from bilateral ureteral orifices.The sidekick needle was placed through the operative port and placed into the patient's urethra.1 ml of coaptite solution was injected at 3 separate sites; one-third of a milliliter was injected at each site.The sites were 2 o'clock, 10 o'clock, and 6 o'clock.The injection sites were hemostatic.The cystoscope was removed.The foley catheter was replaced in the patient's bladder.The posterior colporrhaphy was performed.Dissection was carried out laterally to the pelvic sidewalls.A site-specific posterior colporrhaphy was performed using multiple sutures of 2-0 pds.Once the rectocele was completely reduced, the vaginal epithelium was minimally trimmed and repaired using 2-0 monocryl.A rectal exam demonstrated no further evidence of rectocele, and no suture injury within the rectum.The vaginal packing was placed, and she was awoken and taken to the recovery room in 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: 15071053
• MDR Text Key: 296286960
• Report Number: 3005099803-2022-03921
• 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: 07/20/2022

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
• Device Operator: Health Professional
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/20/2022
• 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: 51 YR
• Patient Sex: Female