• 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 45

Device Problems
Fracture 133
Failure to deploy 119
Deployment issue 107
No Known Device Problem 98
Occlusion within device 81
Difficult to remove 80
Break 70
Detachment of device component 52
Premature deployment 38
Bent 35
Device operates differently than expected 35
Material torqued 34
Difficult to deploy 33
Material twisted 32
Material deformation 26
Failure to advance 22
Device remains implanted 19
Entrapment of device or device component 15
Detachment of device or device component 14
Size incorrect for patient 11
Torn material 11
No Information 11
Leak 10
Blockage within device or device component 9
Sticking 8
Difficult to position 8
Retraction problem 8
Improper or incorrect procedure or method 7
Dislodged or dislocated 7
Migration of device or device component 7
Delivered as unsterile product 7
Kinked 7
Difficult to advance 6
Device damaged prior to use 6
Component missing 6
Mechanical jam 6
Physical resistance 5
Mechanical issue 5
Stretched 5
Strut fracture 5
Loss of or failure to bond 4
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
Malposition of device 3
Device or device component damaged by another device 3
Difficult to insert 3
Positioning Issue 3
Failure to expand 2
Dislodged 2
Tip breakage 2
Therapy delivered to incorrect body area 2
Peeled 2
Improper flow or infusion 2
Tear, rip or hole in device packaging 2
Obstruction within device 2
Structural problem 1
Failure to disconnect 1
Failure to separate 1
Material rigid or stiff 1
Failure to deliver 1
Defective component 1
Incompatibility problem 1
Material Distortion 1
Foreign material present in device 1
Device misassembled during manufacturing or shipping 1
Buckled material 1
Delamination 1
Device, removal of (non-implant) 1
Regenerate 1
Use of Device Issue 1
Resistance, inadequate 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
No code available 1
Scratched material 1
Total Device Problems 1271

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 2
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
7 Terumo Medical Corp II Nov-29-2016

-
-