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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 E1P8
Device Problem Material Integrity Problem (2978)
Patient Problem Hematoma (1884)
Event Date 10/25/2018
Event Type  Injury  
Manufacturer Narrative
We have not received the patch for evaluation since the patch was explanted and was then sent to the pathology department by the hospital. The patient's culture taken in the operating room of the patch and of the hematoma were negative for infection. The surgeon commented that intraoperatively the patch appeared to be friable and inflamed. The operating surgeon told us that usual pre-op hygiene instructions were given to the patient and the patient received pre-op prophylactic antibiotics prior to the skin incision for right cea. We have not yet received the pathology report performed on this explanted patch by the hospital. We have consulted our medical director regarding this case. He believes that the pseudoaneurysm in this case occured as a result of a technical error rather than the defect in the patch. He stated that while taking the suture bites through the artery and the patch, it is essential to take a large enough bite to bring the patch down to the external carotid orifice in such a way that it will hold and not tear though. An insufficient tissue bite at this site can lead to the formation of pseudoaneurysm. He also stated on the comment made by the operating surgeon who stated that the patch appeared to be friable and inflamed when the patch was explanted from the patient's artery. He stated that changes will appear on the patch once it is placed in the artery and when removed weeks after the operation, it can appear to be inflamed. 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. Further, we have not received any other complaints of a similar nature for devices from this lot. Our ifu properly informs users about the potential complications including pseudoaneurysm that can occur with the use of the xenosure bovine pericardial patch. The explanted patch was replaced with the patient's own greater saphenous vein patch that was harvested from his right thigh.
 
Event Description
On (b)(6) 2018, patient underwent right carotid endarterectomy followed by an angioplasty closure of the carotid artery using a xenosure biologic patch catalog# e1p6 lot# xbu3083. On (b)(6) 2018, the patient returned to the hospital with a moderate sized localized hematoma in the superior aspect of the right neck incision. Computed tomography angiography (cta) of the neck performed at the facility diagnosed a pseudoaneurysm with an active bleeding of the carotid artery at the implanted patch site.
 
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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 Key8122025
MDR Text Key129023883
Report Number1220948-2018-00103
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 11/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberE1P8
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/13/2017
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: 12/01/2018 Patient Sequence Number: 1
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