MAUDE Adverse Event Report: ARIS TRANSOBTURATOR KIT; SURGICAL MESH

Lot Number 1776398

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); No Information (3190); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for august-september 2016.This mdr is to reflect the additional and corrected information to be added to the initial asr report.(b)(4).The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

This mdr is created as a follow-up to record 300446, initially reported on product code otn asr exemption # e2014015 for august-september 2016.This mdr is to reflect the additional information to be added to the initial asr report.As reported to coloplast though not verified, patient's legal representative stated.The patient has complained of dyspareunia, decreased libido, pelvic pain, suprapubic pain, urinary incontinence, recurrent uti's and fecal incontinence.(b)(6) 2015 extensive transvaginal ureterolysis and anterior vaginal wall reconstruction due to mesh complication and dyspareunia.The patient has severe incompetent anal sphincter and stool incontinence, lower extremity pain, stress incontinence of stool.The patient had obturator sling surgery in 2009.The patient immediately suffered from complications including dyspareunia, lower extremity pain, fatigue and other systemic symptoms.The patient was diagnosed with ibs, chronic fatigue syndrome and central sensitivity syndrome.The patient has an unusual finding after surgery developed also significant stool incontinence.On examination there was poor sphincter tone and poor ability to hold the contrast in the sphincter that could probably be related to the obturator sling and provider plans to repair.The exploration and removal of mesh from the adductor fossa (gracilis, adductor longus and brevis muscles) and exploration and removal of mesh from adductor fossa and obturator fossa is very complex, delicate and difficult procedure requiring extensive and complex dissection.The mesh was fixed to the periosteum of the pubic bone and the mesh removal required a deep dissection of the pubic bone while preserving vascular supply and avoid nerve injury.

Manufacturer Narrative

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

• Brand Name: ARIS TRANSOBTURATOR KIT
• Type of Device: SURGICAL MESH
• MDR Report Key: 10040477
• MDR Text Key: 193959439
• Report Number: 2125050-2020-00380
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 1776398
• Patient Sequence Number: 1
• Patient Age: 41 YR