MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION FLIXENE 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)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.Per the study, iaavgs allow earlier cannulation and tunneled catheter removal, thereby significantly decreasing catheter related complications.Product not available for return.

Event Description

Received an article titled: dillavou, e.E.(2019).Immediate access arteriovenous grafts decrease catheter days and complications.Vascular access, p.E332.Purpose: this study compares iaavg to standard arteriovenous grafts (savg) as well as describing iaavg use with hero outflow.Method: all patients who underwent placement of av graft from 1/2014 - 4/2016 at two large tertiary referral centers were retrospectively identified in the electronic medical record and through the vascular quality initiative (vqi).Per the article adverse events included occlusion, steal syndrome and graft infection.

• Brand Name: FLIXENE GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 9861713
• MDR Text Key: 186750854
• Report Number: 3011175548-2020-00438
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K071923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 03/20/2020
• 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