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

Model Number AG636

Device Problem Material Integrity Problem (2978)

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

Event Date 08/29/2022

Event Type  malfunction  

Manufacturer Narrative

The graft was successfully implanted on (b)(6) 2022.The issue was identified during a follow-up visit on (b)(6) 2022.As a result, there was no reported adverse event associated with this complaint.Based on the documentation and complaint history review, we do not believe there is a systemic issue with this device.Manufacturing records and necessary logs were reviewed and no deviations or non-confomances were found.This is the only event related to a"dissection flap" in product history.All available information has been provided.This and similar complaints will continue to be monitored and investigated.Additional actions will be performed as deemed necessary.

Event Description

"patient (b)(6) had artegraft placed (b)(6) 2022 as an interposition graft from brachial artery to cephalic fistula.Upon follow up visit 8-29 a dissection flap was noted inside the graft that encompasses approximately 25% of the graft towards the venous end.Graft has not been accessed.".

• 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: 15504809
• MDR Text Key: 306346071
• Report Number: 2247686-2022-00006
• 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: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AG636
• Device Lot Number: 22B055-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2022
• 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