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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stent, superficial femoral artery
Definition Stent, Superficial Femoral Artery -- a metal scaffold placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen
Product CodeNIP
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
5 4 21 19 17 16 21 42 40 6

Device Problems
Failure to deploy 103
Fracture 102
No Known Device Problem 76
Difficult to remove 61
Break 57
Occlusion within device 50
Detachment of device component 48
Deployment issue 45
Device operates differently than expected 29
Difficult to deploy 28
Premature deployment 28
Material twisted 27
Material torqued 26
Material deformation 21
Device remains implanted 19
Failure to advance 18
Size incorrect for patient 11
Leak 10
Detachment of device or device component 10
Torn material 10
Blockage within device or device component 9
Bent 8
Sticking 8
Retraction problem 8
Difficult to position 8
Entrapment of device or device component 7
Improper or incorrect procedure or method 7
Component missing 6
Difficult to advance 6
Dislodged or dislocated 6
Mechanical jam 6
No Information 6
Physical resistance 5
Mechanical issue 5
Migration of device or device component 5
Kinked 5
Strut fracture 5
Material separation 4
Device damaged prior to use 4
Other (for use when an appropriate device code cannot be identified) 3
Unknown (for use when the device problem is not known) 3
Inaccurate delivery 3
Obstruction within device 2
Dent in material 2
Improper flow or infusion 2
Device or device component damaged by another device 2
Malposition of device 2
Tip breakage 2
Difficult to insert 2
Loss of or failure to bond 2
Dislodged 2
Failure to expand 2
No code available 1
Failure to capture 1
Device clogged 1
Delivered as unsterile product 1
Hole in material 1
Peeled 1
Regenerate 1
Use of Device Issue 1
Stretched 1
Material rigid or stiff 1
Resistance, inadequate 1
Delamination 1
Foreign material present in device 1
Incompatibility problem 1
Material Distortion 1
Positioning Issue 1
Scratched material 1
Failure to disconnect 1
Failure to separate 1
Structural problem 1
Device, removal of (non-implant) 1
Tear, rip or hole in device packaging 1
Failure to deliver 1
Total Device Problems 949

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 1 0 1 0 0 0
Class II 0 0 0 0 0 0 1 0 0 0
Class III 0 2 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc I Oct-10-2013
2 Boston Scientific Corporation I Jun-16-2011
3 Cordis Corporation II Jun-06-2013
4 Ev3, Inc III Sep-21-2008
5 Ev3, Inc III Sep-11-2008

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