MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. ARTEGRAFT VASCULAR GRAFT; TISSUE GRAFT OF 6MM AND GREATER

Model Number	AG 640
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The graft was spatulated and sewn into the vein using running 6-0 prolene.At the end of the procedure, the vessels and graft were flushed with good flow.One repair stitch was placed in each of the arterial and venous anastomoses.There was strong flow in the graft to the midportion of the tunneled area but very little flow into the venous area.The tunnel was enlarged manually from both directions to ensure that there was no stricture of the graft.There was not.The graft was opened, and a coronary dilator was passed through the graft as was a fogarty balloon catheter.No clot or other problem was noted.A incision was made over the point of the pulse differential, and the graft was noted to be bruised appearing.The graft was opened, and a dissection flap was seen within the graft.A small portion of the graft was excised and re-anastomosed, but this did not fix the problem.Left ovary graft material from the original trimming of the graft was then used to replace most of the arterial portion of the graft.It was sewn into the venous area at the counter-incision and was sewn into the arterial portion approximately 2 cm from the anastomosis.Following this, there was excellent flow through the graft.The excised portion of the graft was opened on the back table and found to have what appeared to be a dissection within the graft.

• Brand Name: ARTEGRAFT VASCULAR GRAFT
• Common Device Name: TISSUE GRAFT OF 6MM AND GREATER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 206 north center dr.; north brunswick NJ 08902
• MDR Report Key: 20891711
• Report Number: 20891711
• Device Sequence Number: 13022560
• Product Code: LXA
• UDI-Device Identifier: 00316837000244
• UDI-Public: (01)00316837000244
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/04/2024
• Report Date (Section F): 12/04/2024

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
• Operator of Device: Health Professional
• Device Model Number: AG 640
• Device Catalogue Number: AG 640
• Device Lot Number: 23F283-028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 12/04/2024