MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. XENOSURE BIOLOGIC PATCH; INTRACARDIAC PATCH OR PLEDGET

Model Number	e1P6
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a carotid endarterectomy with patch done on 2020.She was presented in 2022 with an infected patch requiring surgical intervention.Fda notified this incident to lemaitre on 5/27/2022.Fda provided lemaitre with a copy of voluntary medwatch report# mw5109514.
Additional Manufacturer Narrative
The copy of the medwatch report# mw5109514 did not disclose the reporter who communicated this incident to fda.Hence, we could not contact the reporter for additional information.We have manufactured a total of (b)(4) units of xenosure patches under this lot.We have sold all of the units.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.Further, we have not received any other complaints of a similar nature for devices from this lot.This lot passed all of the microbiology tests including the sterility test, lal.It is highly unlikely that the infection was related to the xenosure patch considering that the patch was implanted 2 years before when the infection occurred.

• Brand Name: XENOSURE BIOLOGIC PATCH
• Common Device Name: INTRACARDIAC PATCH OR PLEDGET
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; lemaitre vascular, inc.; 63 second ave MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 14799415
• Report Number: 1220948-2022-00055
• Device Sequence Number: 4932898
• Product Code: PSQ
• UDI-Device Identifier: 00840663106288
• UDI-Public: 00840663106288
• Combination Product (Y/N): N
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2022

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 Expiration Date: 05/28/2024
• Device Model Number: e1P6
• Device Catalogue Number: E1P6
• Device Lot Number: XBU3656
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown