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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 1

Device Problems
Fracture 145
Failure to deploy 131
Deployment issue 124
No Known Device Problem 103
Difficult to remove 93
Occlusion within device 90
Break 77
Detachment of device component 53
Bent 49
Premature deployment 42
Material torqued 40
Device operates differently than expected 40
Material twisted 37
Difficult to deploy 34
Failure to advance 28
Material deformation 26
Entrapment of device or device component 21
Device remains implanted 19
Detachment of device or device component 15
Torn material 11
No Information 11
Size incorrect for patient 11
Leak 10
Retraction problem 10
Blockage within device or device component 9
Kinked 9
Difficult to position 8
Sticking 8
Migration of device or device component 8
Improper or incorrect procedure or method 7
Dislodged or dislocated 7
Delivered as unsterile product 7
Stretched 7
Difficult to advance 7
Device damaged prior to use 7
Mechanical jam 6
Component missing 6
Strut fracture 5
Physical resistance 5
Mechanical issue 5
Inaccurate delivery 4
Material separation 4
Dent in material 4
Loss of or failure to bond 4
Unknown (for use when the device problem is not known) 3
Device or device component damaged by another device 3
Other (for use when an appropriate device code cannot be identified) 3
Malposition of device 3
Positioning Issue 3
Difficult to insert 3
Improper flow or infusion 2
Therapy delivered to incorrect body area 2
Dislodged 2
Peeled 2
Obstruction within device 2
Failure to expand 2
Tear, rip or hole in device packaging 2
Tip breakage 2
Incompatibility problem 1
Contamination during use 1
Failure to capture 1
Defective component 1
Regenerate 1
Use of Device Issue 1
Structural problem 1
Buckled material 1
Failure to deliver 1
No code available 1
Delamination 1
Resistance, inadequate 1
Device misassembled during manufacturing or shipping 1
Foreign material present in device 1
Device, removal of (non-implant) 1
Material rigid or stiff 1
Hole in material 1
Device packaging compromised 1
Failure to separate 1
Device clogged 1
Device expiration issue 1
Instruction for use issue 1
Scratched material 1
Material Distortion 1
Failure to disconnect 1
Total Device Problems 1406

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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