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

Catalog Number E0.8P8

Device Problem Peeled/Delaminated (1454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint patch for evaluation and we have confirmed the reported incident with this patch.The patch was observed to have delaminated about 3 cm at one end of the patch.At the same end, we also observed a suture that the surgeon had pierced through the patch.No other defects were noted in this patch.This patch was checked by the operating team before the procedure and was found to be acceptable.During manufacturing, each patch is inspected by our manufacturing as well as by the qc staff for such defect.It is highly unlikely for the inspection team would have missed such a visible defect.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.Therefore, we believe that it was an isolated incident.We have also performed a review of complaint history for such incidents for last 10 years for this device.The rate of occurrence for such incident is (b)(4) which is in line with our risk documents.Our ifu properly instructs users not to use cutting point armed sutures or traumatic instruments during the procedure as this may damage the patch.The patch was then removed and replaced with another patch.

Event Description

Patch started to delaminate while suturing into the carotid artery.

• 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: 8139850
• MDR Text Key: 130626573
• Report Number: 1220948-2018-00104
• 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: Physician
• Type of Report: Initial
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Catalogue Number: E0.8P8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2018
• 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