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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 E0.8P8
Device Problem Delamination (2904)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/22/2017
Event Type  malfunction  
Manufacturer Narrative
We have received the device for evaluation and confirmed the reported incident. We observed about 3 cm of the outermost layer on the smooth side of the patch had peeled off. The layer was not peelable after that point. We could not conclusively determine the root cause of the defect. Device was checked multiple times 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 448 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. We therefore believe this is an isolated incident. There was no injury to the patient as the result of this incident. Procedure was completed by implanting a new dacron patch.
 
Event Description
During carotid patch angioplasty using a xenosure patch, surgeon noticed that the outermost layer of the patch had peeled off at one side of the 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 Key6965860
MDR Text Key90769733
Report Number1220948-2017-00059
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K040835
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberE0.8P8
Device Lot NumberXBU2223
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2016
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: 10/20/2017 Patient Sequence Number: 1
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