MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. FLIXENE IFG VASCULAR GRAFT

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Event Description

Received article published on the american surgeon titled "traditional versus early-access grafts for haemodialysis access: a single-institution comparative study" which was conducted with flixene graft (tpvg) and polyurethaneurea vascular access grafts (ptfe).Over the 2-year period, 65 traditional ptfe and 78 tpvg grafts were placed in consecutive groups.With the use of the flixene graft (tpvg), the need for temporary haemodialysis catheters was reduced from 91% to 32%, and one-year overall graft patency was improved from 36% to 77%.The report states 35 cases of thrombosis with ptfe grafts, but only 23 cases with tpvgs.

Manufacturer Narrative

The study includes two different style vascular grafts, one being atrium medical's flixene vascular graft.In summary, the use of the trilaminate ptfe (flixene) graft allowed early access, reduced the need for temporary hemodialysis catheters, decreased overall graft complication rates and significantly improved one-year patency.We are uncertain if any evaluation has been performed on the devices used in the study because no complaints were previously received and no devices were returned to the manufacturer.We are unable to fully investigate this event as no product code, lot number, or sample was available for investigation.

• Brand Name: FLIXENE IFG VASCULAR GRAFT
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: theresa morin ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3827045
• MDR Text Key: 4448138
• Report Number: 1219977-2014-00137
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• 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: 04/03/2014
• 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): Other