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); Thrombosis (2100)

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, despite the invasiveness, direct atrial outflow procedures remain a valid alternative in carefully selected patients with adequate cardiopulmonary reserve.Product not available for return.

Event Description

Received an article titled: lopez-pena, g.E.(2019).Comparison of axillary-atrial and axillary-iliac arteriovenous grafts for hemodialysis access creation.The journal of vascular access, pp.55-59.Purpose: the aim of this study was to compare two complex vascular access techniques that utilize the axillary artery as inflow and accesses were created with early cannulation grafts: the axillary-atrial arteriovenous graft versus axillary-iliac arteriovenous graft.Method: this is a retrospective study of end-stage renal disease patients with occluded intrathoracic central veins that underwent complex hemodialysis access creation in our institution after failed endovascular recanalization attempts.Per the article adverse events included pseudoaneurysm, thromboembolic events, restenosis and 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: 9861716
• MDR Text Key: 188982751
• Report Number: 3011175548-2020-00439
• 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,foreig
• Reporter Occupation: Other
• 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
• 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