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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 6

Device Problems
Fracture 180
Deployment issue 142
Failure to deploy 138
No Known Device Problem 101
Occlusion within device 100
Difficult to remove 98
Break 83
Bent 56
Detachment of device component 54
Material torqued 47
Premature deployment 45
Material twisted 44
Device operates differently than expected 42
Difficult to deploy 36
Failure to advance 31
Material deformation 28
Entrapment of device or device component 23
Device remains implanted 19
Detachment of device or device component 17
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
Stretched 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
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
Positioning Issue 3
Failure to expand 3
Improper flow or infusion 2
Incompatibility problem 2
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
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
Foreign material present in device 1
Buckled material 1
Delamination 1
Device packaging compromised 1
Device, removal of (non-implant) 1
Failure to deliver 1
Device markings issue 1
Device misassembled during manufacturing or shipping 1
Scratched material 1
No code available 1
Material Distortion 1
Total Device Problems 1537

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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