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

Model Number	AG640
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Bacterial Infection (1735); Post Operative Wound Infection (2446)
Date of Event	12/23/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 206 north center drive; north brunswick NJ 08902 4247
• MDR Report Key: 11737713
• Report Number: 2247686-2021-00002
• Device Sequence Number: 19590338
• Product Code: LXA
• UDI-Device Identifier: 00316837000244
• UDI-Public: (01)00316837000244(17)231031(10)20J232-015
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: N16837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 38 YR