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

Device Problem Positioning Problem (3009)

Patient Problems Erosion (1750); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Prolapse (2475); Unspecified Kidney or Urinary Problem (4503); Urinary Incontinence (4572)

Event Date 07/27/2007

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a transobturator tape placement procedure on (b)(6) 2007, for the treatment of stress urinary incontinence.According to reports, there were no complications during the surgery and the patient was moved to the recovery room in a satisfactory condition.After undergoing the procedure, the patient suffered from recurring urinary tract infections, and there was a possibility of mesh exposure at the bladder neck, which caused chronic pelvic pain and voiding dysfunction.As a result, on (b)(6) 2021, the patient underwent a transvaginal urethrolysis, had the transobturator mesh sling removed, and underwent vaginal reconstruction.On preoperative cystoscopy, the sling appeared to be tight around the urethra with a possible small area of erosion near the bladder neck.Upon examination, the physician was able to identify the sling positioned beneath the urethra at the midpoint of the urethra.Further examination revealed scarring on the vaginal front wall along with a minor cystocele, graded as 1.In order to proceed with the treatment, the doctor removed the periurethral fascia and located the mesh sling, which appeared to be embedded in the periurethral fascia.After separating it from the suburethral tissue, the mesh sling was cut in the center.The right and left mesh arms were dissected sharply and bluntly laterally until they disappeared into the obturator space.The mesh was tightly adherent to the periosteum of the descending pubic ramus and rather difficult to dissect.A periosteum elevator was used to aid in the dissection of the mesh off of the bone.The physician then freed up the rest of the mesh vaginally completely until it disappeared behind the descending pubic ramus.The mesh was then excised just proximal to the inferior pubic ramus in the obturator space bilaterally and was sent to pathology.Furthermore, the patient was then awakened from anesthesia and taken to the recovery room in stable condition.

Manufacturer Narrative

Block b3 (date of event): date of event was approximated to (b)(6) 2007, 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 e1: this event was reported by the patient's legal representation.The implanting surgeon is: dr.(b)(6).The physician who performed the excision: dr.(b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2006 - has been used to capture the reported event of possible mesh erosion.E1311 - has been used to capture the reported event of voiding dysfunction.E2330 - has been used to capture the reported event of chronic pain.E1310 - has been used to capture the reported event of recurring urinary tract infection.E1715 - has been used to capture the reported event of scarring.The following imdrf impact code capture the reportable event of: f1903 - has been used to capture the reported event of mesh excision.

• Brand Name: OBTRYX 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: 17425260
• MDR Text Key: 320115529
• Report Number: 3005099803-2023-04055
• 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: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2023
• 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
• Patient Age: 34 YR
• Patient Sex: Female