MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. ARTEGRAFT; COLLAGEN VASCULAR GRAFT

Model Number AG715

Device Problems Material Puncture/Hole (1504); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2023

Event Type  malfunction  

Event Description

There was a hole in the graft.

Manufacturer Narrative

The graft involved was not received for evaluation so the issue was not able to be confirmed.Additional patient information was requested on (b)(6) 2023 with no updates received as of (b)(6) 2023.Additional request for information was submitted on (b)(6) 2023 to clarify the series of events.No new information was provided to date.A review of complaint data within the past three years was completed and there were no indications or trends identified that would suggest an increase in holes in grafts that have been fully processed.As 100% of the grafts are pressure tested and visually inspected prior to release, we remain inconclusive about the root cause of the issue.Based on the documentation and complaint history review, we do not believe there is a systemic issue with these devices.No further actions were determined to be necessary at this time; all product quality and clinical issues will continue to be monitored within quality assurance trending.

Event Description

The graft was not used and did not come in contact with the patient.The product was stored in their sterile core at operating room normal temperatures.The product was removed from packaging and flushed per ifu packaging.There was no unusual smell, but there was a slit in the graft.

Manufacturer Narrative

Follow-up report 1.Additional information was received: sections b5, d9, h6 were updated.Actual complaint product lot 21k284-055 was returned and evaluation was conducted.Product code and length were verified.The graft was visually inspected by both quality personnel and a manufacturing technician for any signs of abnormality.The inspections did not identify any evidence of a hole or slit in the graft; no issues were identified with the returned product.

• Brand Name: ARTEGRAFT
• Type of Device: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 206 north center drive; north brunswick NJ 08902 4247
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 206 north center drive; north brunswick 08902
• Manufacturer Contact: monte nelson ; 206 north center drive; north brunswick, NJ 08902-4247 ; 7324228333
• MDR Report Key: 18119795
• MDR Text Key: 327931172
• Report Number: 2247686-2023-00008
• Device Sequence Number: 1
• Product Code: LXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N16837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AG715
• Device Catalogue Number: N/A
• Device Lot Number: 21K284-055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• 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