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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 Delamination (2904)
Patient Problem No Information (3190)
Event Date 11/07/2017
Event Type  malfunction  
Manufacturer Narrative
We have received the device for evaluation. However, we could evaluate the complaint device since it was returned to us dry. As a result, the patch has shrinked significantly and had lost all of its physical and chemical properties. We received 5 small pieces of the patch. We could not conclusively determine the root cause of the defect. Device was checked by the operating team prior to the start of the procedure and was found to be acceptable. 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. All qc tests passed their requirements. All of the (b)(4) units of the xenosure patches manufactured in this lot number has been sold. We have not received any other complaints of similar nature for devices from this lot. There was no injury to the patient as the result of this incident. Procedure was completed by implanting a new patch. We have contacted the hospital to provide us with further information on this case. However, we have not yet heard anything back from the hospital.
 
Event Description
Xenosure patch frayed after being sutured in the patient. So, the patch was explanted and replaced with an another patch.
 
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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 Key7100932
MDR Text Key94393230
Report Number1220948-2017-00070
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
Type of Report Initial
Report Date 12/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/05/2017
Device Catalogue NumberE1P6
Device Lot NumberXBU2833
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/10/2017
Was Device Evaluated by Manufacturer? Yes
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: 12/08/2017 Patient Sequence Number: 1
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