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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 7

Device Problems
Fracture 292
Deployment issue 270
Failure to deploy 168
Occlusion within device 161
No Known Device Problem 136
Difficult to remove 116
Break 108
Bent 80
Premature deployment 71
Difficult to deploy 67
Stretched 66
Material torqued 63
Device operates differently than expected 62
Material twisted 61
Entrapment of device or device component 61
Detachment of device component 55
Material deformation 40
Failure to advance 36
Detachment of device or device component 29
Device remains implanted 19
Retraction problem 17
Kinked 15
Torn material 12
No Information 11
Size incorrect for patient 11
Leak 10
Blockage within device or device component 10
Malposition of device 10
Misfire 10
Dislodged or dislocated 9
Migration of device or device component 9
Difficult to advance 9
Difficult to position 9
Device damaged prior to use 8
Sticking 8
Positioning Issue 7
Inaccurate delivery 7
Improper or incorrect procedure or method 7
Delivered as unsterile product 7
Failure to expand 6
Component missing 6
Mechanical issue 6
Mechanical jam 6
Device or device component damaged by another device 5
Strut fracture 5
Physical resistance 5
Loss of or failure to bond 4
Dent in material 4
Device expiration issue 4
Device markings issue 4
Difficult to insert 3
Other (for use when an appropriate device code cannot be identified) 3
Material separation 3
Unknown (for use when the device problem is not known) 3
Use of Device Issue 2
Obstruction within device 2
Defective component 2
Tear, rip or hole in device packaging 2
Contamination during use 2
Tip breakage 2
Device inoperable 2
Incompatibility problem 2
Peeled 2
Therapy delivered to incorrect body area 2
Dislodged 2
Instruction for use issue 2
Improper flow or infusion 2
Delivery system failure 1
Failure to disconnect 1
Material Distortion 1
Scratched material 1
Resistance, inadequate 1
Device, removal of (non-implant) 1
Device misassembled during manufacturing or shipping 1
Foreign material present in device 1
Failure to separate 1
Device packaging compromised 1
Material rigid or stiff 1
Hole in material 1
Device clogged 1
Material integrity issue 1
Failure to capture 1
Structural problem 1
Buckled material 1
Delamination 1
No code available 1
Failure to deliver 1
Regenerate 1
Total Device Problems 2261

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 1
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 II Feb-22-2018
3 Boston Scientific Corporation I Jun-16-2011
4 Cordis Corporation II Jun-06-2013
5 Ev3, Inc III Sep-21-2008
6 Ev3, Inc III Sep-11-2008
7 Ev3, Inc. II Jun-23-2016
8 Medtronic Inc. II Nov-29-2017
9 Terumo Medical Corp II Nov-29-2016

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