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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
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 abstract early cannulation avg is a recommended option when an urgent hemodialysis access is required because it decreases the use of cvc and has an acceptable patency and complications rate.
 
Event Description
Received an abstract titled "early cannulation arteriovenous grafts should be used to reduce central venous catheter".The aim of this abstract was to assess if early cannulation grafts reduces the prevalence and duration of cvc using all patients with an early cannulation avg confection between 2009 and 2014 were included.Per the abstract post-operative complications rate was 26%.
 
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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 Key7343295
MDR Text Key102573766
Report Number3011175548-2018-00283
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 foreign,health professional,l
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 Received03/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received02/26/2018
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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