Society For Clinical Vascular Surgery

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MAUDE Database Entries of Covered Stents: Does it Matter if It Involved an Arteriovenous Access Procedure?
Michael F. Amendola, MD1, Jill Peysha, MD1, Wishnoff Mathew, BS2, Debolina Banerjee, BS2.
1VA Medical Center/VCU Health System, Richmond, VA, USA, 2VCU School of Medicine, Richmond, VA, USA.

BACKGROUND
The Manufacturer and User Facility Device Experience (MAUDE) Database was established by the Food and Drug Administration (FDA) to allow for voluntarily reporting of adverse outcomes with medical devices. Three common commercially available self-expanding covered stents systems: ViabahnTM Stent Graft System (W. L. Gore & Associates), FluencyTM and FlairTM (C. R. Bard, Inc.). We sought to examine MAUDE reporting of these three stent systems in the arteriovenous access (Access) verses other arterial beds (Other).
METHODS
The MAUDE database was access from June 1, 2012 to June 1, 2016 at a single time point for entries related to the ViabahnTM Stent Graft System, FluencyTM and FlairTM in the arteriovenous access and other arterial beds. The time to report from index event, negative patient outcome (death, injury, hematoma, surgery, further intervention), and vessel bed for stent deployment were collected.
RESULTS
A total of 435 entries were found for the time-period examined, comparing the two groups:

Access
N = 245
Other
N = 190
p value
Time to Reporting (days± SD)223 ± 278114 ± 2680.0001**
Negative Patient Outcome (%)16.7%71.6%0.0001*
Devices Returned (%)61.1%16.8%0.0001*

Of the Other entries, the majority were from the femoral popliteal artery segment (n=99, 52.9%) with most of these prostheses being the ViabahnTM Stent Graft System (n=172, 90.5%).
CONCLUSIONS
In our examination of stent graft systems that entries into the MAUDE database, those associated with arteriovenous access procedures had significantly more delay in reporting to the database from the index procedure, fewer negative patient outcomes and more devices returned. These data should inform the vascular surgery community at large that fewer reported negative patient outcomes compared to these devices being deployed in other arterial beds.


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