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

Model Number AG640

Device Problem Contamination (1120)

Patient Problems Bacterial Infection (1735); Post Operative Wound Infection (2446)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

This report captures details related to patient 1 of 2.Refer to mdr-2247686-2021-00003 for details on patient 2.A review of the device history record for product batch 20j323 was re-reviewed and no related nonconformances were identified.The lot generated passing results for sterility testing prior to release to finished goods.The complaint artegraft was not returned for evaluation.In the initial follow-up conversation, the doctor stated that the there was nothing wrong with the packaging boxes, the grafts were prepped according to recommendation.Additional information was requested; including relevant patient medical history/medications/preexisting conditions, and lab results; the information was not provided to date.The issue was not able to be confirmed.No confirmed complaint trend was identified related to the issue.To date, no additional complaints were reported from the product batch 20j323.Artegraft® collagen vascular graft instructions for use (ifu, ls 012 rev.S) dosage and administration section provides instructions for aseptically removing the artegraft from its container.Additionally, the adverse effects section states "disruption of anastomoses, especially in the presence of infection, has been observed and, in a few cases, transient low grade fever, the etiology, of which has not been obvious, has been experienced." a definitive root cause was not established.All product quality and clinical issues will continue to be monitored within quality assurance trending.

Event Description

The doctor mentioned to a sales representative that he would no longer be utilizing artegraft in the groin/leg as he had 4 patients in the last few months that get infected and the graft disintegrated.Upon review of the details, it was later updated that only 2 patients were identified as having artegraft implanted.The following patient information was provided for patient 1: left leg groove avg utilizing an artegraft 5 mm graft on (b)(6) 2020,· emergent exploration, left common femoral with excision of av graft on (b)(6) 2020.Below knee amputation before the graft was implanted and then above knee amputation after the graft implant, likely due to the complications.

• 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: cynthia salter ; 206 north center drive; north brunswick, NJ 08902-4247 ; 7324228333
• MDR Report Key: 11737713
• MDR Text Key: 263569897
• Report Number: 2247686-2021-00002
• Device Sequence Number: 1
• Product Code: LXA
• UDI-Device Identifier: 00316837000244
• UDI-Public: (01)00316837000244(17)231031(10)20J232-015
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: AG640
• Device Catalogue Number: AG 640
• Device Lot Number: 20J323-015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• 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): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 38 YR