• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
5 4 21 19 17 16 21 42 40 21

Device Problems
Fracture 105
Failure to deploy 103
No Known Device Problem 78
Difficult to remove 63
Break 57
Deployment issue 53
Occlusion within device 52
Detachment of device component 50
Device operates differently than expected 30
Premature deployment 29
Difficult to deploy 28
Material twisted 27
Material torqued 26
Material deformation 21
Failure to advance 19
Device remains implanted 19
Size incorrect for patient 11
Detachment of device or device component 11
Leak 10
Torn material 10
Bent 9
Blockage within device or device component 9
Entrapment of device or device component 8
Sticking 8
Retraction problem 8
Difficult to position 8
Improper or incorrect procedure or method 7
Component missing 6
Difficult to advance 6
Dislodged or dislocated 6
Mechanical jam 6
Migration of device or device component 6
Kinked 6
No Information 6
Mechanical issue 5
Strut fracture 5
Physical resistance 5
Material separation 4
Device damaged prior to use 4
Other (for use when an appropriate device code cannot be identified) 3
Unknown (for use when the device problem is not known) 3
Inaccurate delivery 3
Dent in material 3
Difficult to insert 3
Loss of or failure to bond 2
Dislodged 2
Tip breakage 2
Peeled 2
Obstruction within device 2
Positioning Issue 2
Improper flow or infusion 2
Device or device component damaged by another device 2
Malposition of device 2
Failure to expand 2
No code available 1
Buckled material 1
Delamination 1
Foreign material present in device 1
Incompatibility problem 1
Material Distortion 1
Scratched material 1
Structural problem 1
Device, removal of (non-implant) 1
Failure to disconnect 1
Failure to separate 1
Tear, rip or hole in device packaging 1
Failure to deliver 1
Delivered as unsterile product 1
Regenerate 1
Use of Device Issue 1
Stretched 1
Material rigid or stiff 1
Resistance, inadequate 1
Contamination during use 1
Failure to capture 1
Device clogged 1
Hole in material 1
Total Device Problems 982

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 1 0 1 0 0 0
Class II 0 0 0 0 0 0 1 0 0 1
Class III 0 2 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

-
-