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

Model Number 5196501022

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Pain (1994); Dyspareunia (4505)

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.There is no publication citation.This is a conference abstract that has not yet been published in a journal supplement.

Event Description

Abstract title: a0880: single-incision mini-slings versus standard mid-urethral slings in the surgical management of female stress urinary incontinence: an updated systemic review and meta analysis results : meta-analysis demonstrated no significant difference between sims (excluding tvt-secur) and smus for mid-term patient reported success (risk ratio [rr]: 0.98; 95% confidence interval [cl].0.95-1.02) and objective cure rate (rr: 0.97; 95% cl, 0.93- 1.01 ).Long-term data were lacking.Sims demonstrated higher reoperation rates (rr: 1.92; 95% cl, 1.18-3.12), but no significant difference for de-novo dyspareunia (rr: 1.26; 95% cl, 0.57-2.82).Or mesh exposure (rr: 0.98; 95% cl, 0.44-2.20), compared to smus.Favourable surgical data and reduced post-operative pain was observed but remains questionable.Conclusions: excluding tvt-secur, sims there was no evidence of significant difference in patient-reported and objective cure between currently used sims and smus at mid-term follow-up.Results should be interpreted with caution due to the heterogeneity of the trials included.

• 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: 16527198
• MDR Text Key: 311131056
• Report Number: 2125050-2023-00288
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K221874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/13/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 5196501022
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/12/2023
• 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