MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. XENOSURE BIOLOGIC PATCH

Catalog Number	E1P6
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a carotid endarterectomy with patch angioplasty using the xenosure patch.The initial surgery was performed on (b)(6) 2025.The patient came back to the hospital with an infection on (b)(6) 2025.On (b)(6) 2025 the infection was removed and the intervention was repaired with the patient's great saphenous vein.The vascular coordinator did not know the exact cause of the infection.Additional information received states the culture grew strep anginousus.
Additional Manufacturer Narrative
During manufacturing the products are tested to ensure they conform to our specification for sale.Additionally, the report of infection is highly unlikely to be caused by the device itself.The validated sterilization process for the xenosure product is tested against bacillus atrophaeus to ensure that the process is sufficient to prevent microbes/bacteria that would cause infection.Therefore, it is likely that the source of the infection was from the procedure itself.There is no indication that the product sterility was compromised.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests met their requirements.We have not received any other complaints of a similar nature for devices from this lot.

• Brand Name: XENOSURE BIOLOGIC PATCH
• Common Device Name: BIOLOGIC PATCH
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC; 63 second ave; burlington MA 01803
• Manufacturer Contact: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 21718898
• Report Number: 1220948-2025-00060
• Device Sequence Number: 17096109
• Product Code: FTM
• UDI-Device Identifier: 00840663106288
• UDI-Public: (01)00840663106288(11)230628(17)290528(10)XBU7250(91)E1P6
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: E1P6
• Device Lot Number: XBU7250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown