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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL FLIXENE VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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ATRIUM MEDICAL FLIXENE VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Unspecified Infection (1930); Ischemia (1942); Thrombosis (2100); Rupture (2208)
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 they did not demonstrate a benefit to the routine use of heparin bonded ptfe for avg creation especially give the higher cost of these grafts.
 
Event Description
Received an article titled "heparin-bonded polytetrafluorethylene does not improve hemodialysis arteriovenous graft function".The purpose of the article was to compare the patency rates, number of interventions, and complications between heparinized ptfe grafts and non heparin-bonded ptfe grafts placed for dialysis access in all dialysis access procedures between (b)(6) 2013 and (b)(6)2014.Per the article adverse events included: steal syndrome, infection, thrombosis and rupture.
 
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Brand Name
FLIXENE VASCULAR 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 Key7343287
MDR Text Key102575639
Report Number3011175548-2018-00278
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
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
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 02/26/2018
Initial Date FDA Received03/15/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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