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

Model Number AG750

Device Problem Material Puncture/Hole (1504)

Patient Problem Hematoma (1884)

Event Date 05/19/2021

Event Type  malfunction  

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 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
• 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 NJ 08902 4247
• Manufacturer Contact: cynthia salter ; 206 north center drive; north brunswick, NJ 08902-4247 ; 7324228333
• MDR Report Key: 11952288
• MDR Text Key: 264092676
• Report Number: 2247686-2021-00004
• Device Sequence Number: 1
• 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
• Reporter Country Code: US
• PMA/PMN Number: N16837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• 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