• 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 26

Device Problems
Fracture 114
Failure to deploy 107
No Known Device Problem 87
Difficult to remove 68
Break 64
Occlusion within device 63
Deployment issue 63
Detachment of device component 50
Premature deployment 34
Device operates differently than expected 33
Material torqued 33
Difficult to deploy 32
Material twisted 30
Material deformation 23
Failure to advance 20
Device remains implanted 19
Bent 18
Entrapment of device or device component 12
Detachment of device or device component 12
Size incorrect for patient 11
No Information 11
Torn material 10
Leak 10
Blockage within device or device component 9
Sticking 8
Retraction problem 8
Difficult to position 8
Migration of device or device component 7
Kinked 7
Dislodged or dislocated 7
Improper or incorrect procedure or method 7
Component missing 6
Mechanical jam 6
Difficult to advance 6
Physical resistance 5
Device damaged prior to use 5
Strut fracture 5
Mechanical issue 5
Material separation 4
Dent in material 4
Inaccurate delivery 3
Other (for use when an appropriate device code cannot be identified) 3
Unknown (for use when the device problem is not known) 3
Difficult to insert 3
Loss of or failure to bond 3
Dislodged 2
Peeled 2
Stretched 2
Tip breakage 2
Tear, rip or hole in device packaging 2
Obstruction within device 2
Malposition of device 2
Device or device component damaged by another device 2
Improper flow or infusion 2
Positioning Issue 2
Failure to expand 2
No code available 1
Scratched material 1
Incompatibility problem 1
Foreign material present in device 1
Material Distortion 1
Device misassembled during manufacturing or shipping 1
Buckled material 1
Delamination 1
Device, removal of (non-implant) 1
Structural problem 1
Failure to disconnect 1
Failure to separate 1
Use of Device Issue 1
Failure to deliver 1
Material rigid or stiff 1
Resistance, inadequate 1
Regenerate 1
Delivered as unsterile product 1
Contamination during use 1
Failure to capture 1
Device clogged 1
Instruction for use issue 1
Device expiration issue 1
Hole in material 1
Total Device Problems 1092

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

-
-