MAUDE Adverse Event Report: ATRIUM MEDICAL FLIXENE GRAFT W/GDS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number 25052

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

A hero device was implanted for first stage of the operation.The flixene graft was then attached proximally to the super hero device.Once tunneled to the distal artery of the patient it was noticed that the flixene grafts distal end felt thick.The end was cut-off and the rest of the graft was used to anastomose without any issues.

Manufacturer Narrative

The graft sample was returned and evaluated to determine the cause of the complaint.A tactile inspection was performed per the manufacturing procedure and it was noted that the graft had a small hard spot on one end as compared to the rest of the returned graft.The thickness of the graft was normal.Hard spots are inspected for during the manufacturing process.In this case it appears that the manufacturing operator may not have detected the hard spot in the material during the inspection.A review of the manufacturing procedure indicates that the process of inspection requires the manufacturing operators to conduct a tactile inspection on the entire length of the graft.The test procedure instructs the following regarding the tactile inspection: lightly run finger tips along the length of the graft while gently squeezing the graft between the finger and thumb.Feel for any variation in stiffness of the graft.Feel for any hard rings within the graft.Feel for any soft spots within the graft.Flixene eptfe vascular grafts are intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.The instructions for use (ifu) states complications that may occur in connection with the use of any vascular graft include, but are not limited to: thrombosis, stenosis, formation of pseudoaneurysm due to excessive needle punctures, peri-graft hematoma formation, peri-graft seroma formation, excessive needle hole bleeding or weeping, infection, swelling of tissue, suture hole elongation, mechanical disruption, material separation, delamination or tearing of the graft material, suture line or host vessel which may result in extreme blood loss, loss of limb function, steal syndrome, loss of limb or possible death.

Event Description

Not applicable.

• Brand Name: FLIXENE GRAFT W/GDS
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7545540
• MDR Text Key: 109501444
• Report Number: 3011175548-2018-00524
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K060124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2020
• Device Model Number: 25052
• Device Catalogue Number: 25052
• Device Lot Number: 416661
• Other Device ID Number: 00650862250527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Date Manufacturer Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1