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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 29

Device Problems
Fracture 268
Deployment issue 237
Failure to deploy 154
Occlusion within device 140
No Known Device Problem 127
Difficult to remove 107
Break 101
Bent 76
Premature deployment 64
Difficult to deploy 57
Material torqued 56
Detachment of device component 55
Material twisted 54
Stretched 53
Device operates differently than expected 52
Entrapment of device or device component 41
Failure to advance 36
Material deformation 35
Detachment of device or device component 25
Device remains implanted 19
Retraction problem 16
Kinked 14
Torn material 12
No Information 11
Size incorrect for patient 11
Leak 10
Blockage within device or device component 10
Difficult to position 9
Dislodged or dislocated 9
Migration of device or device component 8
Sticking 8
Difficult to advance 8
Malposition of device 8
Inaccurate delivery 8
Device damaged prior to use 8
Improper or incorrect procedure or method 7
Delivered as unsterile product 7
Mechanical issue 6
Component missing 6
Mechanical jam 6
Positioning Issue 6
Failure to expand 5
Physical resistance 5
Device or device component damaged by another device 5
Strut fracture 5
Dent in material 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
Device markings issue 3
Use of Device Issue 2
Tip breakage 2
Misfire 2
Tear, rip or hole in device packaging 2
Obstruction within device 2
Instruction for use issue 2
Contamination during use 2
Dislodged 2
Peeled 2
Therapy delivered to incorrect body area 2
Improper flow or infusion 2
Incompatibility problem 2
Foreign material present in device 1
Material Distortion 1
Material integrity issue 1
Scratched material 1
No code available 1
Regenerate 1
Material rigid or stiff 1
Resistance, inadequate 1
Failure to capture 1
Device clogged 1
Hole in material 1
Structural problem 1
Failure to disconnect 1
Failure to separate 1
Device inoperable 1
Defective component 1
Device packaging compromised 1
Device misassembled during manufacturing or shipping 1
Device, removal of (non-implant) 1
Failure to deliver 1
Buckled material 1
Delamination 1
Delivery system failure 1
Total Device Problems 2039

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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