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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL FLIXENE; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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ATRIUM MEDICAL FLIXENE; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Unspecified Infection (1930)
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 ptfe for revision of aneurysmal or ulcerated arteriovenous fistulae should be considered as an alternative to fistula abandonment.
 
Event Description
Received an abstract titled "outcomes of early cannulation ptfe interposition grafts for salvage of failing arteriovenous fistulae".The purpose of the abstract was to report an institutional experience of early cannulation ptfe when used as an interposition graft for aneurysmal and/or ulcerated arteriovenous fistulas using a prospective qa database identified 46 dialysis patients over a 54 month period who underwent placement of early cannulation ptfe for interposition.Per the abstract adverse events included: infection.
 
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Brand Name
FLIXENE
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 Key7343288
MDR Text Key102575747
Report Number3011175548-2018-00277
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 literature,other
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? 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 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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