MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Catalog Number 519650

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2023

Event Type  malfunction  

Event Description

According to the available information the anchor broke off from mesh during implant.A new sling was used.

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.

Manufacturer Narrative

An altis sling was received for evaluation.Examination of the sling revealed the static anchor detached from the mesh and not received.Visual observation of the mesh where the static suture was attached confirmed the welded area of the suture was still attached.Microscopic examination of the static suture where the anchor had detached revealed rough and irregular surfaces, indicating stress may have been exerted.The dynamic suture was still attached to the mesh as received, along with the dynamic anchor & tensioner.Blood residue was noted on the mesh.The information received indicated the static anchor detached during implant.Quality confirmed the detached static anchor.As the static anchor was not received, it was concluded that the detachment of the static anchor most likely occurred during the tensioning part of the procedure.As the detachment ends of the static suture were rough and irregular, this indicated that excess stress most likely exerted to result in the separation noted.A review of the device history record by the contract manufacturer confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

Event Description

According to the available information the anchor broke off from mesh during implant.A new sling was used.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: FEMALE 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: 18318197
• MDR Text Key: 330387896
• Report Number: 2125050-2023-01565
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 05708932467407
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 519650
• Device Lot Number: 8868325_5196502400
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 04/26/2023
• 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 Sex: Female