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

Model Number AG735

Device Problem Material Integrity Problem (2978)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/08/2021

Event Type  malfunction  

Event Description

Patient had a left arm brachial artery to brachial vein artegraft implanted (b)(6) 2021.On (b)(6) 2021, it was reported clotted by the dialysis center so the doctor performed a thrombectomy and pulled out the clot from the arterial end.The graft was successfully accessed 3-5 times.On (b)(6) 2021 it was again clotted and the doctor performed a second thrombectomy/exploration and again found a clot on the arterial end.The doctor stated that it looked like access sites were closer to this end of graft.Venous end was open.During the procedure the doctor was able to see that the mid portion of the graft looked like the walls of graft had separated.He said it appeared that the intimal wall was just" free-floating" like a straw within the lumen of the graft.He was worried that the graft was faulty so he ligated the graft.The patient continues dialysis on a catheter now and will have a new graft implanted in (b)(6).

Manufacturer Narrative

The graft was not received for evaluation since it remains implanted.Hence, we could not conclusively determine the cause of the failure.Thrombosis is a known possible issue.The instructions for use, adverse reactions section lists thrombosis as a complication.Possible root cause may be low blood flow, inadvertent external compression (e.G., from clothing, etc.), inadequate heparin therapy for the patient, graft rotation/ implantation technique, or the graft may have been used in low pressure system.All grafts released from batch 20k363 met the requirements for release, including pressure testing, sterility testing, and final visual inspection prior to release to finished goods.To date, no additional complaints were reported from this product batch.Based on our investigation this appears to be an isolated incident.All product quality and clinical issues will continue to be monitored within quality assurance trending.

• 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: 13196877
• MDR Text Key: 290138660
• Report Number: 2247686-2021-00005
• Device Sequence Number: 1
• Product Code: LXA
• UDI-Device Identifier: 00316837000282
• UDI-Public: (01)00316837000282(17)231(10)20K363-050
• 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: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: AG735
• Device Lot Number: 20K363-050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2020
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female