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

Model Number AG640

Device Problem Material Integrity Problem (2978)

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

Event Date 05/10/2022

Event Type  malfunction  

Manufacturer Narrative

The lemaitre interpretation is that there were no leaks in the graft wall after being pressure tested pre-operatively by the physician.It was clarified that the malfunction was identified after the tunneling of the graft.A suture repair was used to fix the graft leak.The graft was implanted with success and the patient is doing well.The physician also mention there are no leaks or occlusions per ultrasound in the graft.Our review of the lot history record for batch number 21kk298 did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.During the manufacturing process, the exact graft was inspected by a manufacturing technician for holes in the graft and proper ligation of the tributaries.No defect was noted during the inspection process.All grafts from these product batch numbers were also tested for pressure test.All of the samples met its specification.Further, we have not received any other complaints of a similar nature from possible product batch, 21kk298.Therefore, we believe that it was an isolated incident.We have also reviewed our complaint history records for last 2 years and searched for a similar issue where a leak was found in an artegraft collagen vascular graft after being dilated/tunneled before operation; there is no confirmed trend was identified for this issue.We remain inconclusive about the root cause of the issue, but 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 after suturing the leak; 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.

Event Description

The complaint was reported as "surgeon found leak in graft while dilating graft, said he thinks it was where a side-branch tie had fallen off.".

• 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: timothy stevens ; 206 north center drive; north brunswick, NJ 08902-4247 ; 7324228333
• MDR Report Key: 14643409
• MDR Text Key: 301936196
• Report Number: 2247686-2022-00003
• 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: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AG640
• Device Lot Number: 21KK298-013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Date Device Manufactured: 11/08/2021
• 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: 64 YR
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American