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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stent, iliac
Definition Stent, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen
Product CodeNIO
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
3 4 7 14 23 34 47 33 27 8

Device Problems
Premature deployment 124
Dislodged or dislocated 108
No Known Device Problem 91
Deployment issue 89
Inaccurate delivery 60
Difficult to remove 56
Difficult to deploy 52
Occlusion within device 50
Fracture 33
Migration of device or device component 28
Failure to advance 28
Difficult to position 23
Bent 21
Material frayed 19
Dislodged 17
Device remains implanted 17
Break 16
Detachment of device or device component 15
Material deformation 15
Failure to deploy 14
Size incorrect for patient 14
Device operates differently than expected 13
Material separation 12
Other (for use when an appropriate device code cannot be identified) 12
Device damaged prior to use 12
Entrapment of device or device component 12
Detachment of device component 12
Split 11
Torn material 11
Unintended movement 10
Malposition of device 9
Delivery system failure 9
Unknown (for use when the device problem is not known) 9
Improper or incorrect procedure or method 9
Material rupture 9
Physical resistance 8
Difficult to advance 8
Device markings issue 7
Sticking 7
Material Distortion 6
Not Applicable 5
Device, or device fragments remain in patient 5
Tip breakage 5
Crack 5
Device expiration issue 5
Difficult to insert 5
Kinked 5
Unsealed device packaging 5
Loose 4
Interference 4
Unstable 4
Incorrect or inadequate result 4
No Information 4
No code available 4
Packaging issue 3
Failure to deliver 3
Resistance, inadequate 3
Deflation issue 3
Hole in material 2
Inflation issue 2
Loose or intermittent connection 2
Failure to Adhere or Bond 2
Balloon rupture 2
Therapy delivered to incorrect body area 2
Shaft break 2
Defective component 2
Defective item 2
Tear, rip or hole in device packaging 2
Device, removal of (non-implant) 2
Device or device component damaged by another device 2
Mechanical jam 2
Foreign material present in device 2
Incompatibility problem 1
Material twisted 1
No flow 1
Positioning Issue 1
Folded 1
Patient-device incompatibility 1
Balloon pinhole 1
Catheter withdrawal interference 1
Tipover 1
Device or device fragments location unknown 1
Component missing 1
Material perforation 1
Use of Device Issue 1
Insufficient flow or underinfusion 1
Tears, rips, holes in device, device material 1
Slippage of device or device component 1
Sterility 1
Device Difficult to Setup or Prepare 1
Balloon burst 1
Bleed back 1
Application interface becomes non-functional or program exits abnormally 1
Collapse 1
Foreign material 1
Material fragmentation 1
Displacement 1
Dissection 1
Mislabeled 1
Misplacement 1
Total Device Problems 1208

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

Recalls
Manufacturer Recall Class Date Posted
1 Cook Ireland Ltd. II Sep-01-2012
2 Cook Medical Incorporated II Jan-22-2016
3 Cordis Corporation II Feb-15-2012
4 Cordis Corporation II Jul-31-2008

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