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

Catalog Number UNKNOWN

Device Problem Material Puncture/Hole (1504)

Patient Problem Aneurysm (1708)

Event Date 03/28/2023

Event Type  malfunction  

Manufacturer Narrative

We have not received the product for investigation.Hence, we could not conclusively determine the root cause of the reported incident.The lot number of the product was not provided.Therefore, we're unable to perform a lot review.

Event Description

It was reported patient who received an artegraft in a lower extremity bypass six years ago who developed aneurysmic segments.Patient required a revision procedure to replace the original graft.No other impact was reported.

• Brand Name: ARTEGRAFT COLLAGEN VASCULAR GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC; 63 second ave; burlington 01803
• Manufacturer Contact: peter song ; 63 second ave; burlington 01803 ; 7814251683
• MDR Report Key: 16825448
• MDR Text Key: 314118285
• Report Number: 1220948-2023-00072
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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