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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL ADVANTA VXT GRAFTS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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ATRIUM MEDICAL ADVANTA VXT GRAFTS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Device Problem Occlusion Within Device (1423)
Patient Problems Unspecified Infection (1930); Pseudoaneurysm (2605); No Code Available (3191)
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 study, the patients who received avg, primary and primary assisted patencies ere similar between bca and eptf.
 
Event Description
Received a study titled "bovine carotid artery biologic graft outperforms expanded polytetrafluoroethylene for hemodialysis access".The study was to compare the 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 study the patients who received avg, primary and primary assisted patencies were similar between bca and eptfe.Per the study adverse events occurred including occlusion, infection, steal syndrome and pseudoaneurysm.
 
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Brand Name
ADVANTA VXT 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 Key7333656
MDR Text Key102203026
Report Number3011175548-2018-00244
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? 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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