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

Model Number	AG740
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	03/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our review of the lot history records for batch number 22f294 did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.During the manufacturing process, the exact graft was inspected by a manufacturing technician for holes in the graft and proper ligation of the tributaries.No defect was noted during the inspection process.All grafts from these product batch numbers were also tested for pressure; all of the graft met specifications.A review of complaint data within the past three years was completed and there were no trends identified that would suggest an increase of rupture in grafts post-implant.We have not received any other complaints of a similar nature from product batch 22f294.Therefore, we believe that it was an isolated incident.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.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.As per lemaitre clinical evaluation, the root cause is likely related to infection or an iatrogenic access injury.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 or Problem Description
The graft was originally implanted by dr.(b)(6) on (b)(6) 2023.The implant procedure performed was "fem pop", lower limb bypass and the device was "checked" before the procedure.The patient complained of pain in r groin on friday (b)(6) 2024, was cleared and sent home.The patient returned to the hospital on (b)(6) 2024 and dr.(b)(6) performed surgery to repair the ruptured graft with stents.No patient injury or current status was reported.Product remains implanted and will not be returned for evaluation.

• Brand Name: ARTEGRAFT
• Common Device Name: 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 NJ 08902
• Manufacturer Contact: monte nelson ; 206 north center drive; north brunswick, NJ 08902-4247 ; 7324228333
• MDR Report Key: 19036947
• Report Number: 2247686-2024-00001
• Device Sequence Number: 12510586
• Product Code: LXA
• UDI-Device Identifier: 00316837000299
• UDI-Public: (01)00316837000299(11)220726(17)250628(10)22FF294-020(91)AG740
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: N16837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2025
• Device Model Number: AG740
• Device Lot Number: 22F294-020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN; STATINS; ZARELTO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown