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

Model Number AG745

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/22/2022

Event Type  malfunction  

Event Description

The sales representative attended a case on (b)(6) 2022 at (b)(6) general hospital.The surgeon used a viabhan stent to connect artegraft collagen vascular graft on the venous side and sutured the arterial side.Patient was discharged as planned.The sales representative followed up with the surgeon on 2/17/2022 after the post procedure follow-up (using dopler ultrasound) and was informed that the patients graft had thrombosed.

Manufacturer Narrative

The graft was not received for evaluation since it remains implanted.Hence, we could not conclusively determine the cause of the failure.Patient information and status were requested but information was not received, to date.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 21h219 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.

Event Description

On 03/22/2022, the lemaitre sale reprentative followed-up with the surgeon for additional information.Patient information was provided and the current status of the patient was reported as deceased.No additional inforamtion or specifics were provided related to the cause of patient death.

Manufacturer Narrative

On 03/22/2022, the lemaitre sale representative followed-up with the surgeon for additional information.Patient information (identifier, age, etc.) was provided and the current status of the patient was reported as deceased.Multiple requests were made.To date, no additional information or specifics were provided related to the cause of patient death.

• 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: 13807119
• MDR Text Key: 297339459
• Report Number: 2247686-2022-00001
• Device Sequence Number: 1
• Product Code: LXA
• UDI-Device Identifier: 00316837000275
• UDI-Public: (01)00316837000275(11)210920(17)240828(10)21H219-029(91)AG730
• 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,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AG745
• Device Catalogue Number: AG 730
• Device Lot Number: 21H219-026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• 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: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic