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

Model Number AG740

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

Patient Problems Hemorrhage/Bleeding (1888); Pseudoaneurysm (2605)

Event Date 05/27/2023

Event Type  malfunction  

Manufacturer Narrative

Additional follow-up information was requested including patient treatment information that may have led to the event.To date, no additional information was received.The graft involved was not received for evaluation so the issue was not able to be confirmed.The issue did not occur until after graft had been implanted for 249 days ((b)(6) 2023 ).Bleeding was discovered on (b)(6) 2023 when the patient went back for medical review.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 pseudoaneurysm and bleeding 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 implanted on (b)(6) 2022 creation of right brachail -brachial arteriovenous graft for dialysis access.Bleeding was discovered on (b)(6) 2023 when the patient went back for medical review.The issue was reported as degeneration of artegraft moved over cannulation zone which resulted in pseudoaneurysm and bleeding.Ligation and excision of artegraft and ligation of bronchial vein.Patient is reported as doing fine.

Manufacturer Narrative

Additional information was received.The following sections were updated: a1 - tkl, a4 - 76 kg, a6 - asian, b7 patient info.Section a2 was corrected- 56 years old.

• 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: 17326757
• MDR Text Key: 319134891
• Report Number: 2247686-2023-00006
• Device Sequence Number: 1
• Product Code: LXA
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: N16837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AG740
• Device Catalogue Number: N/A
• Device Lot Number: 21K282-047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Race: Asian