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

Catalog Number E0.8P8

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis (2100)

Event Date 03/14/2019

Event Type  Injury  

Manufacturer Narrative

We have received the complaint patch for evaluation. Two pieces of the xensure patch were returned to us stored in 0. 2% glutareldehyde storage solution. One of the two pieces was an explanted piece of the patch that was initially implanted on (b)(6) 2019 while the other piece was a non-implanted piece of this same patch. The explanted piece of the patch appeared inflamed while the non- implanted piece appeared normal. Histologic examination were performed on both pieces of the patch. In both pieces, the collagen appeared to be well organized and staining consistently. Rbcs and nuclear material were present in both pieces of the patch. The explanted piece contained fibrin, haemorrhage and few inflammatory cells. Xenosure bovine patches are treated with gluteraldehyde crosslinking -nh2 groups of the amino acids to form an amine linkage. Patches are processed to be acellular, preventing transmission of bovine proteins or dna into the host. The resultant cross linking process increases tissue strength to inhibit biodegradation, as well as reduce antigenicity. Care must be taken when suturing the bovine pericardial patch in order to prevent injury to the endothelium of the surrounding artery as it can lead to thrombosis. 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. (b)(4) patches from this lot number were released for sale. All of the patches have been sold including (b)(4) units to this hospital, without any other reported incident. We have not received any other complaints of a similar nature for devices from this lot. 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 for additional information from the surgeon, 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.

Event Description

Xenosure biologic patch was used for vessel closure following endarterectomy procedure. During ultrasound, the surgeon detected distinct blue jet. So, surgeon explanted the patch and replaced it with a new patch.

• 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: 8557740
• MDR Text Key: 143417019
• Report Number: 1220948-2019-00048
• Device Sequence Number: 1
• Product Code: FTM
• 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

• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: E0.8P8
• Device Lot Number: XBU3428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• 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: 04/26/2019 Patient Sequence Number: 1