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

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.

• Brand Name: XENOSURE BIOLOGICAL PATCH
• Type of Device: MESH, 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 Key: 8122025
• MDR Text Key: 129023883
• Report Number: 1220948-2018-00103
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00840663106288
• UDI-Public: 00840663106288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040835
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 12/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Catalogue Number: E1P8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention