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

Catalog Number	E4P4
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patch was implanted during a hectic code perfusion critical laparotomy (post kidney transplant) where patient presented in hemorrhagic shock pre-op.A sample of the graft was sent after being opened (and admittedly handled by multiple people; in contact with patient and patient contaminated instruments/gloves).Said sample came back positive for cultured of candida fungus.Graft was already implanted.No unusual harm or injury has been caused by the incident and patient has since been discharged.
Additional Manufacturer Narrative
The product remains implanted and unavailable to be returned for investigation.Therefore, we could not conclusively determine the root cause of the reported incident.The validated sterilization process for the xenosure product is tested against bacillus atrophaeus to verify the device is supplied sterile.It was stated that the graft was handled by multiple people in contact with the patient and patient contaminated instruments/gloves.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.Review of the device history record did not identify any issues that would cause or contribute to the reported issue.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): PSONG@LEMAITRE.COM; 63 second ave; burlington MA 01803
• Manufacturer Contact: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 21968530
• Report Number: 1220948-2025-00086
• Device Sequence Number: 18246374
• Product Code: FTM
• UDI-Device Identifier: 00840663106318
• UDI-Public: (01)00840663106318(11)230516(17)290428(10)XBU00008000(91)E4P4
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: E4P4
• Device Lot Number: XBU00008000
• 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: 04/08/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2023
• 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: Other
• Patient Sex: Unknown