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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL ADVANTA VXT GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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ATRIUM MEDICAL ADVANTA VXT GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A complaint investigation was not able to be performed as no product code, lot number, or sample was provided.Per the study patients who received avg, primary and primary assisted patencies were similar between bca and eptfe.
 
Event Description
Received an article titled "bovine carotid artery biologic graft outperforms expanded polytetrafluoroethylene for hemodialysis access." the article was to compare outcomes between a bovine carotid artery (bca) biologic graft and expanded polytetrafluoroethylene (eptfe) grafts for hemodialysis access in a recent cohort of patients.Per the article, malfunction was graft failure.
 
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Brand Name
ADVANTA VXT 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 Key7333661
MDR Text Key102468088
Report Number3011175548-2018-00241
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 03/13/2018
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? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? 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
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