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

Model Number 5196502400

Device Problem Separation Problem (4043)

Patient Problem Failure of Implant (1924)

Event Date 12/08/2020

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, reported complaint per material coordinator: "altis anchors were deployed, upon pulling the tensioning suture to approximate altis to urethra, blue suture separated from altis." another altis was used.Device returning.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

Manufacturer Narrative

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

An altis sling was received for evaluation.Examination of the sling revealed the static suture had been detached, but there was indication on the mesh where the static suture had been attached.The dynamic suture was received detached.Microscopic examination of the detachment end of the dynamic suture revealed the end to be rough and irregular, indicating stress was exerted.The detachment end of the mesh on the dynamic side showed the mesh to have curled and monofilament pulled out, indicating stress was exerted.The static anchor, dynamic anchor and tensioner were not received.Blood residue was noted on the mesh.Based on the information received, during tensioning the suture separated.Examination of the returned device confirmed curled mesh and pulled monofilament on the dynamic end of the mesh which indicated that stress most likely was exerted on this area to result in the suture detachment.During tensioning there may not have been enough dynamic suture and while continuing to pull to get a proper fit, excess stress was placed on the dynamic suture and mesh to detach.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.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11122073
• MDR Text Key: 225321539
• Report Number: 2125050-2021-00020
• 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
• Device Lot Number: 7308668
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 08/05/2021
• Patient Sequence Number: 1