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

Model Number	AG 616
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Graft appeared much smaller than stated on packaging.

• Brand Name: ARTEGRAFT VASCULAR GRAFT
• Common Device Name: TISSUE GRAFT OF 6MM AND GREATER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second avenue; burlington MA 01803
• MDR Report Key: 18484423
• Report Number: 18484423
• Device Sequence Number: 9154105
• Product Code: LXA
• UDI-Device Identifier: 00316837000213
• UDI-Public: (01)00316837000213(11)211026(17)240928(10)21JJ263-030(91)AG616
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2023
• Report Date (Section F): 08/17/2023

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 Model Number: AG 616
• Device Catalogue Number: AG 616
• Device Lot Number: 21JJ263-030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2024
• 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: Unknown
• Date Report Sent to FDA: 08/17/2023