MAUDE Adverse Event Report: ATRIUM MEDICAL FLIXENE VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Occlusion (1984); Thrombus (2101); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

We are unable to fully investigate this report as no product number, lot number or sample was provided.Per the physician response to inquiry, "none of the adverse outcomes were directly attributable to the flixene product".This article compares 'real world' performance of savgs and iaavgs.The article concluded iaavgs allow earlier cannulation and tunneled catheter removal, thereby significantly decreasing catheter related complications.

Event Description

Received an article titled "immediate access grafts provide comparable patency to standard grafts, with fewer reinterventions and catheter related complications".The purpose of the article was to compare ¿real-world¿ performance of standard av grafts and immediate access av grafts.Per the article adverse events included: steal syndrome, graft infection, occlusion and thrombus.

• Brand Name: FLIXENE VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 8243936
• MDR Text Key: 132934631
• Report Number: 3011175548-2019-00068
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: No
• 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