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

Catalog Number E1P6

Device Problem Delamination (2904)

Patient Problem No Information (3190)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

We have received the device for evaluation. However, we could evaluate the complaint device since it was returned to us dry. As a result, the patch has shrinked significantly and had lost all of its physical and chemical properties. We received 5 small pieces of the patch. We could not conclusively determine the root cause of the defect. Device was checked 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 (b)(4) 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. There was no injury to the patient as the result of this incident. Procedure was completed by implanting a new patch. We have contacted the hospital to provide us with further information on this case. However, we have not yet heard anything back from the hospital.

Event Description

Xenosure patch frayed after being sutured in the patient. So, the patch was explanted and replaced with an another 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: 7100932
• MDR Text Key: 94393230
• Report Number: 1220948-2017-00070
• 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: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/05/2017
• Device Catalogue Number: E1P6
• Device Lot Number: XBU2833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 12/08/2017 Patient Sequence Number: 1