Aris transobturator System

Description of Event or Problem

As reported to Coloplast, though not verified: the patient had an Aris implanted in (b)(6) 2021. Reportedly the patient experienced vaginal discharge "[did report having yeast infection after taking antibiotic after surgery]", abnormal urinary analysis (moderate leukocytes), mesh exposure right side of urethra, nocturia, dyspareunia, increased urinary frequency, incomplete emptying, pelvic pain, urinary urgency and change in urinary stream. Claimant felt something pop in her right side and reported having sensations of foreign body in her vagina that was also felt by her husband. Patient reportedly also experienced exposure of sling bilaterally and loss of "[urinary control. The patient underwent excision of eroded bladder sling via general anesthesia in (b)(6) 2025. Pathology showed benign squamous-lined fibroconnective tissue with chronic inflammation. Post excision, patient reportedly continued to experience urinary loss of control, difficulty urinating, incomplete emptying, pelvic pain, change in urinary stream and abnormal urinary analysis.

Additional Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and CAPA. Devices met specification prior to release. No trends were noted for complaints and there were no nonconforming reports or CAPAs that were confirmed to be associated.The device was not returned for evaluation. Without the benefit of analyzing the device, Quality cannot comment on the condition of the device. Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.