MAUDE Adverse Event Report: ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH

Model Number 5196502400

Device Problem Separation Problem (4043)

Patient Problem Failure of Implant (1924)

Event Date 12/01/2020

Event Type  malfunction  

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.Once our evaluation is complete, a follow-up report will be submitted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

According to the available information, though not verified, malfunctioned.Suture came off of mesh after implanted.Another device was implanted.

Manufacturer Narrative

As no lot number was provided, the contract manufacturer could not complete a device history review of the lot number.Based on the available information, the reported complaint is identified in the risk management documentation and reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.

Event Description

According to the available information the altis sling was to be implanted on (b)(6) 2020 but was not as the suture came off of the mesh after being implanted.Another device was used to successfully complete the surgery.A partial altis sling and detached dynamic suture was received for evaluation.Examination of the returned sling revealed the suture was not attached, but the weld area was noted.The detachment end through the sling showed straight surfaces, indicating it most likely was cut by a sharp instrument.No static anchor, dynamic anchor or tensioner were received for evaluation.Based on examination of the returned mesh and suture, it was concluded that the sling was placed as expected, but during tensioning enough force may have been exerted on the dynamic suture resulting in detachment from the mesh.The detachment through the mesh most likely was a result of removing the mesh to implant another one successfully.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• MDR Report Key: 11168487
• MDR Text Key: 227037864
• Report Number: 2125050-2021-00056
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 12/21/2020
• Supplement Dates FDA Received: 08/04/2021
• Patient Sequence Number: 1
• Patient Age: 66 YR