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

Model Number 5195501000

Device Problem Missing Information (4053)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

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, reported per end user: "in 2016 i had the aris sling put in and it's now only 4 years later and it has erosion and a lot of pain haven¿t had any sex life since then, now divorced as of 2018 i¿m having to have surgery to remove this due to erosion and infection on (b)(6)!" additional information received 09/03/2020 from tm: "patient had both an aris and restorelle directfix anterior mesh placed in 2016.From my observation in the case the erosion/exposure was located midline in the anterior vaginal wall and it was the restorelle mesh that had become exposed not the aris sling.Physician removed the exposed mesh and then performed cystoscopy.Everything with the aris sling appeared to be intact with no visible erosion/exposure and was left alone.".

Manufacturer Narrative

Based on the available information, the reported complaint is identified in the risk management documentation and reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

This follow-up mdr is created to document the additional event information received for record #611189.According to the available information the date of the aris procedure was in 2016.Information received from the end user indicated: ¿in 2016 i had the aris sling put in and it's now only 4 years later and it has erosion and a lot of pain haven¿t had any sex life since then , now divorced as of 2018 , i¿m having to have surgery to remove this due to erosion and infection on (b)(6)".Additional information received (b)(6) 2020 from tm: "patient had both an aris and restorelle directfix anterior mesh placed in 2016.From my observation in the case the erosion/exposure was located midline in the anterior vaginal wall and it was the restorelle mesh that had become exposed not the aris sling.Physician removed the exposed mesh and then performed cystoscopy.Everything with the aris sling appeared to be intact with no visible erosion/exposure and was left alone." see tw 612198 for complaint on restorelle.No components were received for evaluation.As examination of the components may not conclusively confirm or disprove the report of infection quality accepts the physician¿s observations as to the reason for surgical intervention.As no lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.

Manufacturer Narrative

Correction: item number portions of this event were previously reported under manufacturer report number 2125050-2022-00066; since that time, the complaint records were determined to be duplicates and 730099 has been merged into 611189.Any additional information received regarding this event will be submitted under this manufacturer report number, 2125050-2020-00897.

Event Description

Additional info received on 1/20/2022- legal representative stated that the patient was experiencing dyspareunia, pelvic pain, groin pain, vaginal pain, and recurrent urinary incontinence.Also stated erosion and exposure.The device is still implanted.Additional info received on 11/1/2022: 09/01/2016 left anterior thigh pain and weakness 07/16/2020 mesh erosion, sui 09/02/2020 repair of cystocele and excision of restorelle directfix under general anesthesia.

• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 10591376
• MDR Text Key: 208722799
• Report Number: 2125050-2020-00897
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5195501000
• Device Catalogue Number: 519551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female