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

Model Number AG740

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 05/21/2023

Event Type  Injury  

Event Description

There was a hole in the graft near the end when pressure tested so surgeon cut the end off and used a second artegraft to sew end to end anastomosis to make up for the length needed.Per dr melton there was no great antegrade and retrograde doppler pulses after anastomosis.

Manufacturer Narrative

Artegraft instructions for use (ifu) indications for use section states that the use of artegraft for femoropopliteal bypass should be reserved for those patients where the autologous saphenous vein is absent or inadequate.It is also not recommended for reconstruction across the knee joint.However, in the absence of other viable alternatives, the surgeon may well find the benefit to risk ratio warrants its use as an attempted limb salvage procedure.The graft involved was not received for evaluation so the issue was not able to be confirmed.Additional patient information requested, including status and condition of graft, was received 31may2023; the graft was not patent and despite limb salvage options, patient required an aka on (b)(6) 2023.The patient was reported as stable and was discharged on (b)(6) 2023 to inpatient rehab.Additional request for information was submitted 15jun2023 to clarify series of events leading to the aka.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.".

• 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: 17174334
• MDR Text Key: 317629983
• Report Number: 2247686-2023-00004
• 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
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• 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: 23BB066-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2023
• 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): Required Intervention; Disability
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White