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	Bacterial Infection (1735)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for investigation.Therefore, we were unable to conclusively determine if the product contributed to the incident.The reported issue was reviewed and information provided to our microbiology manager for evaluation.The validated sterilization process for the xenosure product is tested against bacillus atrophaeus, which is more resilient than staphylococcus aureus.The sterilization process would kill this bacterium.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.The lot history record for the device was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.We have not received any similar complaints related to this lot number.
Event or Problem Description
It was reported that post carotid endarterectomy with xenosure patch angioplasty, the patient came back with a staphylococcus infection originating from the patch site.The infected patch was removed and the patient's carotid was repaired with application of native gsv graft.

• 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: 19322843
• Report Number: 1220948-2024-00106
• Device Sequence Number: 7648859
• Product Code: FTM
• UDI-Device Identifier: 00840663106288
• UDI-Public: (01)00840663106288
• 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): 05/15/2024

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: E1P6
• Device Lot Number: XBU6964
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2023
• 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; Required Intervention
• Patient Sex: Unknown