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

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

Patient Problems Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Obstruction/Occlusion (2422); Fibrosis (3167); Dyspareunia (4505)

Event Date 07/01/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage fit system was implanted into the patient during a total vaginal hysterectomy mid-urethral sling (mesh), salpingectomy, cystoscopy, and possible anterior repair procedures performed on (b)(6) 2021, for the treatment of stress urinary incontinence, menorrhagia, uterine mass, and fibroids.There were no patient complications reported at the conclusion of the procedure, and the patient's condition was reported to be stable.On (b)(6) 2022, the patient experienced partial obstruction of the urethra from the sling with recurrent urinary tract infections (uti), dyspareunia, and pelvic pain.The patient underwent a transvaginal excision of a sling procedure.During the procedure, resistance was encountered to the passage of the sling at the level of the mid urethra, consistent with partial urethral obstruction by the sling.The sling was found to be implanted at the mid-urethra in the proper location.The sling was found to be placed in the proper vesicovaginal space between the muscularis of the vagina and the muscularis of the bladder, confirming proper sling placement.The sling was embedded within a dense scar plate, completely enveloping the sling.The sling was found to be partially obstructing the urethra.The sling was dissected away from the mid urethra bilaterally, and measurement of the sling in situ showed that the sling width was 0.5 cm, thus confirming that the sling had shrunk by 50% of its pre-implant width.There was bridging fibrosis within the sling pores and poor collapse.The mid-portion of the sling was cut in the midline, dissected bilaterally away from the midline, excised, and examined grossly bilaterally.The scar plating, poor collapse, shrinkage, degradation, and bridging fibrosis of the sling were confirmed by gross examination.The obstruction of the urethra was found to be released upon removal of the sling.Note was made that the urine was cloudy at the time of the catheter placement, consistent with a new urinary tract infection from the sling obstruction.With the portion of the sling now excised, the anterior vagina was closed with a suture, and the procedure was terminated.The patient was transferred to the recovery room in satisfactory condition.On (b)(6) 2022, the patient underwent neurolysis of sling and reduction labiaplasty plus examination under anesthesia.Preoperative diagnosis includes chronic pelvic pain from a prior sling procedure and labial hypertrophy.Postoperative diagnosis includes chronic pelvic pain from a previous sling procedure, labial hypertrophy, and chronic scarring from previous sling surgery.The patient was transferred to the recovery room in satisfactory condition.Urine was clear throughout the entire case.

Manufacturer Narrative

Block b3: date of event was approximated to (b)(6) 2022, revision procedure date, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is dr.(b)(6) (b)(6) hospital (b)(6).Revision surgery performed by dr.(b)(6).Block h6: patient code e1405 captures the reportable event of dyspareunia.Patient code e2313 captures the reportable event of fibrosis.Patient code e2328 captures the reportable event of obstruction/occlusion.Patient code e2401 captures the reportable event of scar tissue.Patient code e2330 captures the reportable event of pain.Patient code e1310 captures the reportable event of urinary tract infection.Impact code f1905 captures the reportable event of revision surgery performed.Impact code f1901 captures the reportable event of additional surgery performed.

• 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: 17436838
• MDR Text Key: 320165957
• Report Number: 3005099803-2023-04019
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/01/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 08/01/2023
• 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; Other
• Patient Age: 40 YR
• Patient Sex: Female