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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 9

Device Problems
Fracture 217
Deployment issue 158
Failure to deploy 142
Occlusion within device 121
No Known Device Problem 108
Difficult to remove 101
Break 85
Bent 61
Detachment of device component 54
Premature deployment 51
Material torqued 50
Material twisted 48
Device operates differently than expected 45
Difficult to deploy 38
Failure to advance 33
Material deformation 28
Entrapment of device or device component 27
Device remains implanted 19
Detachment of device or device component 17
Stretched 16
Retraction problem 12
Torn material 12
No Information 11
Size incorrect for patient 11
Kinked 10
Leak 10
Blockage within device or device component 10
Sticking 8
Difficult to position 8
Migration of device or device component 8
Device damaged prior to use 8
Improper or incorrect procedure or method 7
Difficult to advance 7
Dislodged or dislocated 7
Delivered as unsterile product 7
Mechanical issue 6
Component missing 6
Mechanical jam 6
Physical resistance 5
Device or device component damaged by another device 5
Strut fracture 5
Inaccurate delivery 5
Dent in material 4
Malposition of device 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
Tip breakage 2
Use of Device Issue 2
Tear, rip or hole in device packaging 2
Obstruction within device 2
Instruction for use issue 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
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 1671

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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