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

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.

• 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: 6965860
• MDR Text Key: 90769733
• Report Number: 1220948-2017-00059
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040835
• Number of Events Reported: 1
• 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 Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: E0.8P8
• Device Lot Number: XBU2223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2016
• 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