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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 3

Device Problems
Fracture 172
Failure to deploy 136
Deployment issue 130
No Known Device Problem 103
Occlusion within device 97
Difficult to remove 95
Break 81
Detachment of device component 54
Bent 53
Premature deployment 43
Material torqued 43
Device operates differently than expected 41
Material twisted 40
Difficult to deploy 35
Failure to advance 29
Material deformation 27
Entrapment of device or device component 22
Device remains implanted 19
Detachment of device or device component 15
Torn material 12
No Information 11
Retraction problem 11
Size incorrect for patient 11
Kinked 10
Leak 10
Blockage within device or device component 9
Sticking 8
Stretched 8
Difficult to position 8
Migration of device or device component 8
Delivered as unsterile product 7
Difficult to advance 7
Dislodged or dislocated 7
Improper or incorrect procedure or method 7
Device damaged prior to use 7
Component missing 6
Mechanical jam 6
Physical resistance 5
Strut fracture 5
Mechanical issue 5
Loss of or failure to bond 4
Material separation 4
Dent in material 4
Inaccurate delivery 4
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
Device or device component damaged by another device 3
Difficult to insert 3
Positioning Issue 3
Failure to expand 2
Dislodged 2
Tip breakage 2
Peeled 2
Therapy delivered to incorrect body area 2
Improper flow or infusion 2
Tear, rip or hole in device packaging 2
Obstruction within device 2
Structural problem 1
Failure to disconnect 1
Failure to separate 1
Failure to deliver 1
Defective component 1
Incompatibility problem 1
Foreign material present in device 1
Material Distortion 1
Device packaging compromised 1
Device misassembled during manufacturing or shipping 1
Buckled material 1
Delamination 1
Device, removal of (non-implant) 1
Regenerate 1
Use of Device Issue 1
Material rigid or stiff 1
Resistance, inadequate 1
Contamination during use 1
Failure to capture 1
Device clogged 1
Instruction for use issue 1
Device expiration issue 1
Hole in material 1
Scratched material 1
No code available 1
Total Device Problems 1478

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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