MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. FLIXENE VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Received an article titled "use of the flixene vascular access graft as an early cannulation solution" published in the journal of vascular surgery in 2015.The study consisted of evaluating early cannulation of a prosthetic graft involving 44 pts from 2011 through 2013 and reporting the midterm patency and complication rates.Per the study, one pt had the graft removal at 2 months due to suspicion of infection.Cultures were negative.

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number, or sample was provided.Per the study, it suggests that cannulation of the flixene graft within 1 week after implantation is safe and effective.Early cannulation avoids or shortens the need for a temporary catheter.One-year patency rates appeared to be comparable to those achieved with conventional grafts.Related mdr's: 1219977-2015-00118, 1219977-2015-00120, 1219977-2015-00121, 1219977-2015-00122, 1219977-2015-00123, 1219977-2015-00124.

• Brand Name: FLIXENE VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: lori gosselin, sr. complaints ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 4691844
• MDR Text Key: 17334256
• Report Number: 1219977-2015-00119
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2015

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: 03/31/2015
• Initial Date FDA Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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