MAUDE Adverse Event Report: ATRIUM MEDICAL FLIXENE GRAFTS; 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); 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.This study supports the use of brachiobasilic arteriovenous fistulas as third choice after radiocephalic and brachiocephalic arteriovenous fistulas.It also showed good results with a new type of prosthetic graft that allows cannulation within days of implantation.

Event Description

Received an article titled "comparison among transposed brachiobasilic, brachiobrachial arteriovenous fistulas and flixene vascular graft." the article was to compare the outcomes of 3 upper arm access types: transposed brachiobasilic arteriovenous fistula, autogenous brachial vein-brachial artery access, and a new type of eptfe graft, in a consecutive series of patients treated in a tertiary centre.Per the article adverse events included: steal syndrome.Pseudoaneurysm.Venous outflow stenosis.Thrombosis.Discrete forearm edema.Aneurysmal dilation.

• Brand Name: FLIXENE GRAFTS
• 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: 7341888
• MDR Text Key: 102512996
• Report Number: 3011175548-2018-00274
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• 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
• Is the Reporter a Health Professional?: Yes
• 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