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

Model Number	AG750
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the graft for evaluation since the graft remains implanted.Hence, we could not conclusively determine the cause of the failure.As this is a known possible issue, instructions for use include instructions for pressure testing each graft prior to implant.The preparation for implant section states, "artegraft is manometry pressure tested and quality inspected.Before implanting, occlude one end of graft and pressure test with syringe filled with saline solution." the preimplant pressure test required per the ifu was performed by the customer and did not identify any leaks with the graft.As the pre-implant pressure test did not identify any leaks and the graft was implanted for 23 days prior to the issue, it is likely that the issue was caused after the implant procedure.All grafts released from batch 21b048 passed the requirements for release, including pressure testing, sterility testing, and final visual inspection prior to release to finished goods.To date, no additional complaints were reported from this product batch.Based on our investigation this appears to be an isolated incident.All product quality and clinical issues will continue to be monitored within quality assurance trending.
Event or Problem Description
The graft was implanted on (b)(6) 2021 femoral to popliteal bypass procedure.No issues occurred during the procedure.The malfunction was detected on (b)(6) 2021.This graft was not used for access.The patient was bleeding out through a hole in the graft about 6cm south of proximal anastomosis.The surgeon surgically repaired the hole with ptfe.The patient was reported as "doing fine" after the procedure.

• Brand Name: ARTEGRAFT
• Common Device Name: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 206 north center drive; north brunswick NJ 08902 4247
• MDR Report Key: 11952288
• Report Number: 2247686-2021-00004
• Device Sequence Number: 1153502
• Product Code: LXA
• UDI-Device Identifier: 00316837000312
• UDI-Public: (01)00316837000312(11)210323(17)240228(10)21B048-007(91)AG750
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: N16837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2021

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?: Yes
• Operator of Device: No Information
• Device Expiration Date: 02/28/2024
• Device Model Number: AG750
• Device Catalogue Number: AG 750
• Device Lot Number: 21B048-007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention