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U.S. Department of Health and Human Services

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

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LEMAITRE VASCULAR, INC. XENOSURE BIOLOGICAL PATCH MESH, SURGICAL Back to Search Results
Catalog Number E1P6
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Thrombosis (2100)
Event Date 08/20/2018
Event Type  Injury  
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 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.
 
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Brand NameXENOSURE BIOLOGICAL PATCH
Type of DeviceMESH, SURGICAL
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
pragya thikey
63 second ave
burlington, MA 01803
7812212266
MDR Report Key8357848
MDR Text Key136745849
Report Number1220948-2019-00013
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040835
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 02/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberE1P6
Device Lot NumberXBU2955
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/11/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/21/2019 Patient Sequence Number: 1
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