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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 2018
5 4 21 19 17 16 21 42 40 50 34 2

Device Problems
Fracture 280
Deployment issue 260
Failure to deploy 163
Occlusion within device 152
No Known Device Problem 132
Difficult to remove 110
Break 105
Bent 79
Premature deployment 69
Stretched 65
Difficult to deploy 63
Material torqued 59
Material twisted 57
Device operates differently than expected 56
Detachment of device component 55
Entrapment of device or device component 54
Material deformation 40
Failure to advance 36
Detachment of device or device component 27
Device remains implanted 19
Retraction problem 17
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
Migration of device or device component 9
Difficult to advance 9
Dislodged or dislocated 9
Malposition of device 8
Device damaged prior to use 8
Sticking 8
Delivered as unsterile product 7
Improper or incorrect procedure or method 7
Inaccurate delivery 7
Positioning Issue 7
Mechanical jam 6
Failure to expand 6
Component missing 6
Misfire 6
Mechanical issue 6
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
Difficult to insert 3
Device expiration issue 3
Material separation 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
Tip breakage 2
Device inoperable 2
Use of Device Issue 2
Tear, rip or hole in device packaging 2
Obstruction within device 2
Peeled 2
Therapy delivered to incorrect body area 2
Instruction for use issue 2
Contamination during use 2
Dislodged 2
Improper flow or infusion 2
Incompatibility problem 2
Material Distortion 1
Material integrity issue 1
Scratched material 1
No code available 1
Failure to capture 1
Device clogged 1
Hole in material 1
Regenerate 1
Material rigid or stiff 1
Resistance, inadequate 1
Structural problem 1
Failure to deliver 1
Defective component 1
Device misassembled during manufacturing or shipping 1
Device packaging compromised 1
Foreign material present in device 1
Device, removal of (non-implant) 1
Failure to disconnect 1
Failure to separate 1
Buckled material 1
Delamination 1
Delivery system failure 1
Total Device Problems 2171

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Class I 0 0 0 0 1 0 1 0 0 0 0 0
Class II 0 0 0 0 0 0 1 0 0 2 1 0
Class III 0 2 0 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 Medtronic Inc. II Nov-29-2017
8 Terumo Medical Corp II Nov-29-2016

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