MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. XENOSURE BIOLOGICAL PATCH; MESH, SURGICAL

Catalog Number	E1P6
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have not received the patch for evaluation since the patch remains implanted in the patient.Hence, we could not conclusively determine the root cause of the issue.Surgeon stated that the clot was observed on the patch during revision on (b)(6) 2018.He informed us that the smoother side was correctly implanted so that it faces towards the blood flow and the patch was correctly rinsed per the ifu.We have received a total of 4 complaints related to 6 xenosure patches in last 10 years for this issue.The current rate of occurrence of (b)(4) is within our expected rate of occurrence.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.Four hundred ninety seven patches from this lot number were released for sale.All of the patches have been sold.We have not received any other complaints of a similar nature for devices from this lot.Unfortunately, our analysis was limited to only the information provided and no physical sample was available to us for investigation.We therefore remain inconclusive about the root cause of this issue, but based on the documentation and complaint history review, we do not believe there is a systematic issue with the xenosure patch.Although we requested case histories, only limited information was provided to us.So, it could not be determined if some anatomical or procedural factors may have contributed to this series.Our ifu addresses the potential complications including thrombosis that are associated with the use of xenosure patch.The ifu also adequately instructs users on proper rinsing and implantation technique.Please note that we have also submitted manufacturer's report numbers: 1220948-2019-00014 and 1220948-2019-00015 for the other two cases of thrombosis that were reported by the same surgeon.
Event or Problem Description
During a routine sales call, surgeon mentioned a series of 3 carotid endarterectomy patients who were readmitted due to blood clots.This is report 1 of 3 of that series.

• Brand Name: XENOSURE BIOLOGICAL PATCH
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 8357848
• Report Number: 1220948-2019-00013
• Device Sequence Number: 2284665
• Product Code: FTM
• UDI-Device Identifier: 00840663106288
• UDI-Public: 00840663106288
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/20/2019

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: 08/28/2023
• Device Catalogue Number: E1P6
• Device Lot Number: XBU2955
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention