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

Catalog Number	E6P8
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During manufacturing, the product goes through our validated sterilization process to ensure that the risk of infection from microbes/bacteria that would cause infection is minimized.While the exact cause/source of the infection remains unknown, it is likely that the source of the infection was from the procedure itself.There is no confirmation that the product sterility was compromised.The reported issue is a possible complication associated with the use of this product.As stated in the ifu: the long-term durability of bovine pericardial tissue is unknown.Potential complications include: restenosis, pseudoaneurysm formation, infection, thrombosis, calcification, fibrosis, vessel occlusion, patch rupture, dilation, myocardial infarction, bleeding, stroke and death.The production and traceability record for the device was reviewed; no issues were found during manufacturing or packaging that would cause or contribute to the reported event.All quality control tests were completed successfully and met specification.We have not received any other complaints of a similar nature for devices from this lot.
Event or Problem Description
It was reported that the xenosure tested positive on culture for cutibacterium acnes.The cause was attributed to possible or contamination.The product was implanted.It is not known what actions, if any, were taken to treat or resolve the infection, as specific details of the event were not provided.No other patient injury or complications was reported.

• 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: 25016969
• Report Number: 1220948-2026-00104
• Device Sequence Number: 9542410
• Product Code: FTM
• UDI-Device Identifier: 00840663106806
• UDI-Public: (01)00840663106806(11)250801(17)310728(10)XBU00009274(91)E6P8
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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 Catalogue Number: E6P8
• Device Lot Number: XBU00009274
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• 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