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

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

Patient Problems Edema (1820); Unspecified Infection (1930); Ischemia (1942); Pain (1994); Thrombosis (2100); Stenosis (2263); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

A complaint investigation was not able to be performed as no product code, lot number, or sample was provided.A review of complaints was performed and there have not been any similar reports related to a device malfunction.Review of capa log shows none initiated for this issue.Review of recall folder reveals none initiated for this type of event.Per the article, mid-term follow up results demonstrate patency rates comparable with those of the synthetic avf.The rate of complications, although slightly higher than that with traditional synthetic avf, is still acceptable in this population with no option for access.

Event Description

Received an article titled "early results of brachial arterio-arterial prosthetic loop (aapl) for hemodialysis." the article was to report results using the brachial synthetic arterio-arterial loop, which has been used in a significant number of patients with reasonable follow up.Per the article adverse events included: thrombosis, stenosis, ischaemia, infection, pseudoaneurysm, pain and distal edema.

• Brand Name: FLIXENE 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: 7341123
• MDR Text Key: 102469605
• Report Number: 3011175548-2018-00271
• 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: foreign,health professional,l
• Type of Report: Initial
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2018
• 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