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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL FLIXENE GRAFTS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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ATRIUM MEDICAL FLIXENE GRAFTS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Device Problem Output Problem (3005)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Type  Injury  
Manufacturer Narrative
A complaint investigation was not able to be performed as no product code, lot number, or sample was provided.Per the article, it is important to consider the haemodynamic consequences when utilizing central vessels for vascular access, particularly in the presence of underlying cardiac and vascular disease.
 
Event Description
Received an article titled "high output cardiac failure following formation of an axillo-iliac arteriovenous graft for hemodialysis." the article was to report a further variation in a patient approaching vascular access exhaustion, which resulted in significant and unexpected complications.Per the article adverse events included hypotension and cardiac failure.
 
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Brand Name
FLIXENE GRAFTS
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 Key7333657
MDR Text Key102201999
Report Number3011175548-2018-00247
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 03/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2018
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 Received02/21/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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