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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stent, renal
Definition Stent, Renal -- a metal scaffold placed via a delivery catheter into the renal artery to maintain the lumen
Product CodeNIN
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 1 3 10 13 25 11 14 7 3

Device Problems
No Known Device Problem 19
Difficult to remove 13
Failure to advance 11
Dislodged or dislocated 10
Device remains implanted 7
Occlusion within device 6
Detachment of device component 5
Improper or incorrect procedure or method 4
Migration of device or device component 3
Inaccurate delivery 3
Size incorrect for patient 2
Burst 2
Inflation issue 2
Difficult to insert 2
Difficult to deploy 2
Failure to deploy 1
Dislodged 1
Device, or device fragments remain in patient 1
Unsealed device packaging 1
Difficult to position 1
Premature deployment 1
Kinked 1
Leak 1
Break 1
Deflation issue 1
Sterility 1
Sticking 1
Strut fracture 1
Unstable 1
Use of Device Issue 1
Device damaged prior to use 1
Material separation 1
Shaft break 1
Deployment issue 1
Material deformation 1
Total Device Problems 111

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