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

Device Problem Defective Device (2588)

Patient Problems Abdominal Pain (1685); Micturition Urgency (1871); Inflammation (1932); Pain (1994); Scar Tissue (2060); Discomfort (2330); Dyspareunia (4505); Insufficient Information (4580)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2019 was chosen as a best estimate based on the date of the mesh removal surgery.Reported lot number ml0002910 does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The explant surgeon is: (b)(6).(b)(4).The removed 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 obtryx transobturator mid-urethral sling system device was implanted into the patient during a procedure performed on (b)(6) 2015 for the treatment of uterovaginal prolapse with multiple pelvic floor defects and urinary incontinence.Following the implant, the patient experienced chronic pelvic pain, urinary urgency, abdominal pain, dyspareunia and other complications and symptoms.As a result, on (b)(6) 2019, the patient had to undergo removal of the device and during the removal surgery, it was discovered that the sling had migrated.Despite the surgical intervention, the patient continued to suffer chronic debilitating pain, inability to have sexual relations without severe pain, continuous urinary problems and inflammation of the pelvic tissue.Reportedly, the patient has experienced significant medical and physical pain and suffering, permanent injury, severe injuries and emotional distress, disability, permanent scarring, mental anguish, expense of hospitalization, extensive medical and nursing care and treatment in the past and in the future, and aggravation of pre-existing medical conditions.

• 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: 11869470
• MDR Text Key: 252145214
• Report Number: 3005099803-2021-02286
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/24/2021

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/24/2021
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 44 YR