MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH

Model Number 5196502400

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Micturition Urgency (1871); Pain (1994); Kidney Infection (4502); Dyspareunia (4505); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.Doi: 10.1016/j.Tjog.2022.07.011.

Event Description

A review of the following abstract was performed: schiavi mc, carletti v, yacoub v, cardella g, luffarelli p, valensise hcc, palazzetti p, spina v, zullo ma.Evaluation of the efficacy and safety of single incision sling vs tvt-o in obese patients with stress urinary incontinence: quality of life and sexual function analysis.Taiwan j obstet gynecol.2023 jan;62(1):89-93.Doi: 10.1016/j.Tjog.2022.07.011.Pmid: 36720557.The aim of the study is to demonstrate the best stress urinary incontinence (sui) surgical technique for women with a body mass index higher than 30.This is a retrospective multicenter study from january 2016 to december 2018 of over 159 women with sui who underwent surgery.Seventy-eight women underwent tvt-o and 81 minin-sling technique.Patients were monitored for 36 months by analyzing symptoms, voiding diary, quality of life and sexual activity through standardized questionnaires.Results: complications had a low incidence in both groups and inter-group differences were superimposable.Only groin pain was statistically higher after tvt-o than after mini-sling (12.8% vs1.2%, ¼ 0.03).At 36 months of follow-up, a statistically significant decrease in positive stress test (%) and qtip test (grade) was observed in both groups with no differences between them (p ¼ 0.54 and p ¼ 0.32respectively).The mean number of daily voids was higher after tvt-o (p ¼ 0.04) than after altis (p ¼ 0.22) with a significant difference in favor of the altis group (p ¼ 0.03).After 36 months, there were no significant differences between groups in terms of quality of life and sexual activity.Pgi-i did not show any difference between groups (p ¼ 0.21).Conclusion: tvt-o and minisling had the same efficacy and results in the surgical treatment of sui in obese women.Both techniques relieved their symptoms and improved their quality of life without any significant difference except for a lower incidence of post- mini-sling complications.Complications from table 2 for the altis group include groin pain (1), tape extrusion (2), urinary tract infections (3), dyspareunia (1), de novo urgency (2), de novo sui (5).

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• 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: 16483398
• MDR Text Key: 310673372
• Report Number: 2125050-2023-00256
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 05708932467407
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K221874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• 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: 54 YR
• Patient Sex: Female