MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANSOBTURATOR KIT; SURGICAL MESH

Model Number 5195512400

Device Problem Migration (4003)

Patient Problems Bacterial Infection (1735); Pain (1994); Scar Tissue (2060); Device Embedded In Tissue or Plaque (3165); Dyspareunia (4505)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

As reported to coloplast, though not verified, the patient with this device experienced recurrent utis and poor bladder drainage since the installation of her sling due to ureteral stenosis.Pain was evidenced.Reports of pain with intercourse and vaginal pain.Pain on exam at the location of right inguinal mesh placement.Mesh exposure was observed, muscular groin pain, leg pain, foreign material in vagina, urethral scarring, infected mesh to the right of the midline.Removal of the aris vaginal sling, removal of vulvar mesh with exploration of the obturator space, urethral lysis, vaginal paravaginal, dissection and mesh removal from the deep obturator internus muscles, anterior colporrhaphy, removal of right abdominal wall mesh.This was a very difficult surgery due to scarring from previous surgery and the dissection required to remove the mesh from the left and right groin that was very deeply implanted.The sling was placed in a tangential fashion at the bladder neck with the right being more cephalad and the left in the vaginal wall.This was very difficult due to the significant muscle mass as well as the very deep mesh placement and the attachment to the pubic bone.On (b)(6) 2020 pathology report: aris coloplast mesh removal showed fibromuscular tissue with giant cell reaction to foreign material.

• Brand Name: ARIS TRANSOBTURATOR KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12564787
• MDR Text Key: 274454270
• Report Number: 2125050-2021-01416
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• Combination Product (y/n): N
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/01/2021

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
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 10/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR