MAUDE Adverse Event Report: COLOPLAST A/S VIRTUE MALE SLING SYSTEM; MALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Catalog Number 50020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Perforation (2001); Urinary Retention (2119)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Method- prospective descriptive analysis of surgeries for sui treatment with suburethral sling placement and artificial urinary sphincter (aus) in centers between 2018 and 2021.The data was registered in the saturn study of the european association of urology (eau[) research foundation (eau rf) eau-rf 2016-01.It was analyzed demographic characteristics, urological data and diagnostic work-up, surgery characteristics and complications.In addition, continence and quality of life outcomes were assessed (pre and post-surgery) using the iciq and eq-5d-5l questionnaires, respectively.Results- study included 57 patients mean age of 67 years.The causes of sui were previous radical prostatectomy (82.5%), transurethral surgery (10.5%), radical cystectomy (3.6%) and radiotherapy without prostatectomy (3.5%).In addition, previous urethral dilatation or urethrotomy was reported in 16% and 15.2% of patients treated with a sling and aus, respectively.Diagnosis work-up included a urodynamic study (94.7%) which showed sui in 70.2% (75% and 66.7% in the group treated with sling and aus, respectively.Urodynamics showed mixed ui in 22.8% of cases.The mean pad-test value was 199.71g (sd 110.88) and 534.71g (sd 316.58) for sling and eua, respectively.Treatment for sui was 33 patients with eua, 21 with advancetm xp® and 3 with virtue®.In 9.1% who underwent eua, a previous device was explanted (1 advance®, 4 ams® and 1 zsi®) due to erosion (2), infection (1) and malfunction (3).The most commonly used cuffs for eua were 4-4.5 cm (38.6%).The study recorded 1 urethral perforation, 8.8% urinary retention, 1.8% infection (66.7% associated with diabetes) and 50.9% scrotal haematoma.The reoperation rate was 0% in the sling and 18% in eua groups, with six explants (2 erosions, three infections and one mechanical failure).In terms of functional outcomes, one year after surgery, 53% of sling patients reported no leaks or leaks occurring less than once a week, compared to 73% of those with aus.Leaks occur with physical exercise in 40% of patients.Leakage before reaching the toilet was reported by 29% and 13% of patients with sling and aus, respectively.Some limitation of usual activities was reported by 50% of patients with a sling and moderate limitation by 16% of those with a eua.Conclusion - radical prostatectomy (rp) is the leading cause of sui in men.Both suburethral sling and eua are good therapeutic options with a low complication rate.However, patients should be informed about functional results after surgery as mild urine leaks may persist.

Manufacturer Narrative

Title - surgery for stress urinary incontinence in males: presurgical characteristics, associated complications, changes in continence parameters and quality of life evaluation.Authors- medina polo j., peña vallejo h., teigell tobar j., calzas montalvo c., caro gonzález m.P., alonso isa m., garcía gómez b., arrébola pajares a., rodríguez antolín a., romero otero j.

• Brand Name: VIRTUE MALE SLING SYSTEM
• Type of Device: MALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18349577
• MDR Text Key: 330814514
• Report Number: 2125050-2023-01612
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K101297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 50020
• Is the Reporter a Health Professional?: Yes
• 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): Other
• Patient Age: 67 YR
• Patient Sex: Male