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

Catalog Number	E0.8P8
Medical Device Problem Codes	Material Discolored (1170); Fluid/Blood Leak (1250); Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the xenosure biologic patch that was used during a carotid endarterectomy procedure was different in coloring, texture and felt different (wouldn't contour, felt hard/leathery).The surgeon chose to use the patch and not replace the device with another one.It was reported that as a result of the patch being stiffer and feeling different, the device took longer to sew than normal which resulted in leakage from the site during the procedure.Although the procedure was delayed, the surgeon was successful in completing the procedure using the device.No further complications have been reported.
Additional Manufacturer Narrative
The product remains implanted and is not available for evaluation.Therefore, the reported event was unable to be confirmed.Although the surgeon reported the patch to be stiffer than normal resulting in difficulty during use, the procedure was successfully completed using the device and no additional complications have been reported.The ifu states, "the xenosure should be stored at room temperature.Refridgeration is not required." 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.During manufacturing the devices are tested for proper thickness and stiffness.Patches deemed too thick for use are rejected during the manufacturing process.All qc tests passed their requirements.Further, 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): LEMAITRE VASCULAR, INC; 63 second ave; burlington MA 01803
• Manufacturer Contact: peter song ; 63 second ave; burlington 01803 ; 7814251683
• MDR Report Key: 17930588
• Report Number: 1220948-2023-00172
• Device Sequence Number: 15059333
• Product Code: FTM
• UDI-Device Identifier: 00840663106295
• UDI-Public: (01)00840663106295
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 10/13/2023

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 Expiration Date: 08/28/2024
• Device Catalogue Number: E0.8P8
• Device Lot Number: XBU4008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2018
• 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
• Patient Sex: Unknown