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 Problem Urinary Tract Infection (2120)

Event Date 04/21/2021

Event Type  Injury  

Manufacturer Narrative

Virtue male sling for stress urinary incontinence in men with spinal cord injury: a prospective evaluation and short-term outcomes author: gomes, cristiano; henriques, joão victor; ferreira, luccas la; de bessa junior, jose; bruschini, homero; bissoli, julio; moromizato, julyana.

Event Description

Abstract (english): introduction: there are few options for the surgical treatment of neurogenic stress urinary incontinence (nsui) in men.The use of synthetic tapes has been described, but little data is available.We present shortterm efficacy and safety data of the virtue(r) male sling in a cohort of patients with nsui due to spinal cord injury.Methods: nine consecutive men with a mean age of 40.3 ± 12 years (range 20-57 years) with urodinamically proven nsui were treaten with a vitue sling between february of 2016 and october to 2018 and included in this prospective study.All performed clean intermittent catheterization.Efficacy outcomes included the number of pads used per day, the patient global impression of improvement questionnaire (pgi-i) and quality of life (qol) question regarding their lower urinary tract symptoms consisting of a five point likert scale ranging from pleased to unhappy (0 = pleased; 1 = mostly satisfied; 2 = equally satisfied/unsatisfied; 3 = mostly unsatisfied; 4 = unhappy).We also evaluated the safety profile and complications.Results: preoperatively, the average diaper usage was: 4.1 ± 1.6 diapers/day (2-6 diapers/day).The average cystometric capacity was 403 ± 83.9 ml, all had normal compliance and the mean valsalva leak point pressure was 49.1 ± 19.9 cmh2o.The mean time from sci to sling surgery was 66.6 ± 25.8 months.At a mean follow-up of 16.4 ± 7.3 months (range 7 to 30) the number of diapers/ day decreased to 1.2 ± 0.97 (p = 0.003).Based on the pgi-i, the overall success rate was 70.5%, with a median score of 2 (much better).Regarding qol, three patients were pleased, four were mostly satisfied and only one was mostly unsatisfied.There were no intraoperative complications.Two patients had afebrile urinary tract infection requiring antibiotics in the early postoperative stage.No patients complained of pain after the procedure and no patients had urethral erosion or needed sling explantation.Conclusion: with a median-term follow-up, the virtue mal sling seems to be a feasible option to treat neurogenic stress urinary incontinence in selected men.Longer follow-up and larger cohorts will be needed to further confirm these results and refine the selection criteria for the optimal patient.

• 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: 18350135
• MDR Text Key: 330755235
• Report Number: 2125050-2023-01613
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: Health Professional
• 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: 40 YR
• Patient Sex: Male