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

Catalog Number	0.6BV8
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has not been made available for investigation.Additional information and details of the issue were requested but have not been made available.Therefore, we could not conclusively determine the root cause of the reported incident.Review of complaints over the past year has not identified any trend or increase in related issues.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 passed their requirements.We have not received any other complaints of a similar nature for devices from this lot.
Event or Problem Description
It was reported that a patient had a carotid operation that triggered a post-operative stroke, which required re-intervention.The surgeon suspects a possible device failure related to the adhesion of the device of the implanted device.No further complications were reported to the patient.Additional information including the precise implant date, details of the procedure and intervention were requested.Additional information was also requested related to the additional issues that have occurred, but no additional information has been made available at this time.

• 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: 21533523
• Report Number: 1220948-2025-00044
• Device Sequence Number: 20797731
• Product Code: FTM
• UDI-Device Identifier: 00840663106745
• UDI-Public: (01)00840663106745(11)231023(17)270928(10)XBA6857(91)0.6BV8
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2025

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: 0.6BV8
• Device Lot Number: XBA6857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2023
• 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