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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 2017
5 4 21 19 17 16 21 42 40 50 8

Device Problems
Fracture 213
Deployment issue 150
Failure to deploy 140
Occlusion within device 119
No Known Device Problem 106
Difficult to remove 99
Break 84
Bent 60
Detachment of device component 54
Material torqued 49
Material twisted 46
Premature deployment 45
Device operates differently than expected 43
Difficult to deploy 38
Failure to advance 31
Material deformation 28
Entrapment of device or device component 27
Device remains implanted 19
Detachment of device or device component 17
Stretched 14
Torn material 12
No Information 11
Size incorrect for patient 11
Retraction problem 11
Kinked 10
Leak 10
Blockage within device or device component 9
Sticking 8
Difficult to position 8
Migration of device or device component 8
Delivered as unsterile product 7
Improper or incorrect procedure or method 7
Device damaged prior to use 7
Difficult to advance 7
Dislodged or dislocated 7
Component missing 6
Mechanical issue 6
Mechanical jam 6
Physical resistance 5
Device or device component damaged by another device 5
Strut fracture 5
Dent in material 4
Inaccurate delivery 4
Loss of or failure to bond 4
Material separation 4
Positioning Issue 4
Failure to expand 3
Difficult to insert 3
Device expiration issue 3
Other (for use when an appropriate device code cannot be identified) 3
Unknown (for use when the device problem is not known) 3
Malposition of device 3
Tip breakage 2
Use of Device Issue 2
Tear, rip or hole in device packaging 2
Obstruction within device 2
Dislodged 2
Peeled 2
Therapy delivered to incorrect body area 2
Improper flow or infusion 2
Incompatibility problem 2
Material Distortion 1
Scratched material 1
No code available 1
Regenerate 1
Material rigid or stiff 1
Resistance, inadequate 1
Contamination during use 1
Failure to capture 1
Device clogged 1
Hole in material 1
Instruction for use issue 1
Structural problem 1
Failure to disconnect 1
Failure to separate 1
Defective component 1
Buckled material 1
Delamination 1
Delivery system failure 1
Device, removal of (non-implant) 1
Failure to deliver 1
Device packaging compromised 1
Foreign material present in device 1
Device markings issue 1
Device misassembled during manufacturing or shipping 1
Total Device Problems 1628

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 1 0 1 0 0 0 0
Class II 0 0 0 0 0 0 1 0 0 2 0
Class III 0 2 0 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
6 Ev3, Inc. II Jun-23-2016
7 Terumo Medical Corp II Nov-29-2016

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