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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 14

Device Problems
Fracture 234
Deployment issue 181
Failure to deploy 146
Occlusion within device 130
No Known Device Problem 110
Difficult to remove 104
Break 88
Bent 66
Premature deployment 56
Detachment of device component 55
Material torqued 55
Material twisted 53
Device operates differently than expected 50
Difficult to deploy 46
Failure to advance 35
Entrapment of device or device component 32
Material deformation 30
Stretched 25
Detachment of device or device component 21
Device remains implanted 19
Retraction problem 16
Kinked 12
Torn material 12
No Information 11
Size incorrect for patient 11
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
Inaccurate delivery 7
Difficult to advance 7
Dislodged or dislocated 7
Delivered as unsterile product 7
Mechanical issue 6
Component missing 6
Mechanical jam 6
Positioning Issue 5
Failure to expand 5
Physical resistance 5
Malposition of device 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
Tip breakage 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
Use of Device Issue 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
Device inoperable 1
Defective component 1
Device packaging compromised 1
Foreign material present in device 1
Device markings issue 1
Device misassembled during manufacturing or shipping 1
Buckled material 1
Delamination 1
Delivery system failure 1
Device, removal of (non-implant) 1
Failure to deliver 1
Total Device Problems 1801

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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