MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. ARTEGRAFT; COLLAGEN VASCULAR GRAFT

Model Number AG745

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2022

Event Type  malfunction  

Event Description

"artegraft came back positive for cutibacterium acnes from culture taken of it prior to implanting.".

Manufacturer Narrative

Given the type of organism found on the product, it is likely that the organism came from the handling of the graft just prior to implantation, as it would not have survived the sterilization process due to the graft remaining sealed in the sterilization solution pre and post sterilization.Based on the documentation and complaint history review, we do not believe there is a systemic issue with these devices.No corrective action is needed at this time.The issue was identified during pre-implant preparation and the graft was successfully implanted; there was no reported patient adverse event.The complaint issue will continue to be monitored within quality assurance trending and if action is required, appropriate investigation will be performed.

• Brand Name: ARTEGRAFT
• Type of Device: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 206 north center drive; north brunswick NJ 08902 4247
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 206 north center drive; north brunswick NJ 08902 4247
• Manufacturer Contact: monte nelson ; 206 north center drive; north brunswick, NJ 08902-4247 ; 7324228333
• MDR Report Key: 15174989
• MDR Text Key: 304717576
• Report Number: 2247686-2022-00004
• Device Sequence Number: 1
• Product Code: LXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N16837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AG745
• Device Lot Number: 03/28/2025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male