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

Model Number 5195501400

Device Problems Calcified (1077); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Dyspareunia (4505); Vesicovaginal Fistula (4512); Urinary Incontinence (4572)

Event Date 12/16/2016

Event Type  Injury  

Manufacturer Narrative

This event was previously reported via asr on 26feb2019 (exemption number e2014015).This report is intended to be a follow-up report to submit additional information that has been received.Any further details received will be submitted under this new manufacturer report number.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast, though not verified, the patient experienced severe pain with daily activities and intercourse, urinary incontinence, physical deformity, and the loss of the ability to perform sexually.Additional information received further reported that in (b)(6) 2016 the patient was experiencing or had experienced calcified sling exposure to the right of midline.Surgical revision was planned.Cystourethroscopy with local anesthesia, renal and pelvic ultrasounds were performed.Transvaginal excision of the mid urethral sling took place under general anesthesia due to exposure.Bilateral retrograde pyelograms, and cystoscopy were also noted.It was also noted that there was a one millimeter vesicovaginal fistula just right of the midline and approximately two centimeters posterior to the trigone.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.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

Additional information received on 07 jun 2022 indicated that the patient underwent robotic vesicovaginal fistula repair, creation of a peritoneal flap, and cytoscopy with bilateral ureteral catheter placement.Reported intraoperative findings noted severe adhesion of the ovaries, tubes, and bowel to the area of interest which significantly increased surgical time.

• 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: 11859705
• MDR Text Key: 251913187
• Report Number: 2125050-2021-00587
• Device Sequence Number: 1
• Product Code: OTN
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5195501400
• Device Catalogue Number: 519550
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 06/08/2022
• Supplement Dates FDA Received: 06/14/2022
• 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): Required Intervention; Other
• Patient Age: 56 YR
• Patient Sex: Female