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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 Improper or Incorrect Procedure or Method (2017)
Patient Problems Occlusion (1984); Thrombosis (2100)
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, the modification of the original insertion technique, as described in this article, will reduce infectious and clotting events by eliminating the simultaneous use of the hero and dialysis catheter.
 
Event Description
Received an article titled "early use conversion of the hero dialysis graft.Journal of vascular surgery." the study was to report the modified insertion technique for the hero device to allow early access and avoid the infectious complications previously reported.Per the article adverse events included: occlusion.Thrombosis.
 
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Brand Name
FLIXENE 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 Key7341041
MDR Text Key102464789
Report Number3011175548-2018-00268
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
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 Received02/21/2018
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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