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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL FLIXENE GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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ATRIUM MEDICAL FLIXENE GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
Manufacturer Narrative
A complaint investigation was not able to be performed as no product code, lot number, or sample was provided.This study supports the use of brachiobasilic arteriovenous fistulas as third choice after radiocephalic and brachiocephalic arteriovenous fistulas.It also showed good results with a new type of prosthetic graft that allows cannulation within days of implantation.
 
Event Description
Received an article titled "comparison among transposed brachiobasilic, brachiobrachial arteriovenous fistulas and flixene vascular graft." the article was to compare the outcomes of 3 upper arm access types: transposed brachiobasilic arteriovenous fistula, autogenous brachial vein-brachial artery access, and a new type of eptfe graft, in a consecutive series of patients treated in a tertiary centre.Per the article one graft failure occurred: one patient had low graft velocities that remained low despite central venous stenosis angioplasty.
 
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Brand Name
FLIXENE GRAFT
Type of Device
PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Manufacturer (Section G)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key7341892
MDR Text Key103148210
Report Number3011175548-2018-00275
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
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
Date FDA Received03/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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