MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANSOBTURATOR SYSTEM; SUTURE/NEEDLE PASSER, SINGLE-USE

Catalog Number	519551 / 93-4400
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erosion (1750); Inflammation (1932); Pain (1994); Perforation (2001); Abnormal Vaginal Discharge (2123); Intermenstrual Bleeding (2665); Fibrosis (3167); Dyspareunia (4505); Urinary Incontinence (4572)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
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 in veeva to be associated.The device was not returned for evaluation.Without the benefit of analyzing the device, coloplast 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.B3: estimated date.
Event or Problem Description
As reported to coloplast, though not verified: the patient was implanted with an aris device in (b)(6) 2021 for stress urinary incontinence (sui).A revision procedure was performed to remove a portion of the aris device in (b)(6) 2022 due to erosion.In (b)(6) 2024, another procedure was performed to remove the remainder of the aris mesh due to erosion.It is alleged that the patient suffered and continues to suffer serious and permanent injuries, including pelvic, groin, and vaginal pain, erosion, failure of the aris to treat her sui, worsening sui, and the need for multiple painful surgeries to revise and remove the eroded aris device.
Additional Manufacturer Narrative
This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint and the device not being returned for evaluation a thorough investigation could not be executed.Should additional information become available, this file will be re-evaluated and updated according to current procedures.
Event or Problem Description
As additionally reported to coloplast, though not verified the patient also experienced: being able to feel the sling, bleeding during intercourse, mesh exposure, constant urinary leakage, visible/protruding sling on examination, dyspareunia.The patient underwent removal of mesh erosion, cystoscopy, posterior colporrhaphy and perineoplasty.A pathology report noted eroded vaginal sling ¿ benign squamous vaginal mucosa with associated foreign material, fibrosis, and minimal chronic inflammation consistent with clinical mesh material.Post (b)(6) 2024 procedure, the patient experienced vaginal bleeding, severe vaginal pain, vaginal discharge, bacterial vaginosis, a small opening on the left side of perineum and vaginitis.In (b)(6) 2024, in-office excision of small piece of intravaginal mesh was performed.
Additional Manufacturer Narrative
H6: medical device problem code a24 was removed.

• Brand Name: ARIS TRANSOBTURATOR SYSTEM
• Common Device Name: SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 21071860
• Report Number: 2125050-2025-00018
• Device Sequence Number: 8398833
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Catalogue Number: 519551 / 93-4400
• Device Lot Number: 7180840_5195512400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 03/05/2025; 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female