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

Model Number 5195501000

Device Problems Material Erosion (1214); Obstruction of Flow (2423)

Patient Problems Prolapse (2475); Unspecified Kidney or Urinary Problem (4503); Fecal Incontinence (4571); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Lot number: 5619020-051.(b)(4).This event was previously submitted via asr on 30jun2017 (record id (b)(4)).Portions of this event were also submitted via asr on 24jun2019 (record id (b)(4)).Since that time, record (b)(4) has been merged with record (b)(4).This report is intended to be a follow-up report to submit additional information that has been received.Any further information warranting a follow-up report will be submitted under this new manufacturer report number, 2125050-2021-00613.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 nocturia, urge incontinence, graft erosion, incontinence, frequency, incomplete emptying, urinary tract infection, severe pain with daily activities and intercourse, physical deformity, and the loss of the ability to perform sexually.Additional information received further reported that between may 14th, 2008 and august 23rd, 2017, the patient experienced: small aris erosion near small (½ - 1 cm) vaginal polyp with granulation tissue, in-office vaginal polyp removal (cryoablation), pathology: vaginal polyp ¿ fibroepithelial, benign.Aris erosion improved and vaginal polyp granulation tissue resolved.Low sensory volumes, abnormal flow suggestive of obstruction vs decreased detrusor contractility, urinary tract infection (+) klebsiella pneumoniae.Increased leak point pressure secondary to sling, unable to hold large amounts of urine, urinary retention related to aris vs oxybutynin.Partial excision of aris for mesh erosion, another manufacturer¿s product was used for vaginal colpopexy/paravaginal repair with sacrospinous ligament fixation, cystoscopy x 2.

Manufacturer Narrative

H6 code e1311 applied to capture "weak urine stream" and "stream is slow to start then gushes".

Event Description

Additional information received further reported that between (b)(6) 2006 and (b)(6) 2008 the patient was experiencing or had experienced persistent overactive bladder.Urgency and urge incontinence were refractory to oral medications, and sensory urgency.De novo urgency and urge incontinence post tot placement - described as quite severe.Incomplete emptying with weak urine stream.In (b)(6) 2012 the patient had a grade 2-3 rectocele, paravaginal defect grade-1 midline, and fecal incontinence.Urine stream was slow to start, then gushes.Between (b)(6) 2014 and (b)(6) 2015, the patient underwent flexible cystourethroscopy and botox injections for overactive bladder.

• Brand Name: ARIS TRANSOBTURATOR KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11872783
• MDR Text Key: 261316247
• Report Number: 2125050-2021-00613
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5195501000
• Device Catalogue Number: 519550
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/24/2021
• Supplement Dates Manufacturer Received: 07/31/2021
• Supplement Dates FDA Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR