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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 0

Device Problems
Premature deployment 123
Dislodged or dislocated 104
No Known Device Problem 89
Deployment issue 85
Inaccurate delivery 60
Difficult to remove 55
Difficult to deploy 51
Occlusion within device 48
Fracture 33
Migration of device or device component 27
Failure to advance 26
Difficult to position 23
Bent 21
Material frayed 19
Dislodged 17
Device remains implanted 17
Material deformation 15
Break 15
Size incorrect for patient 14
Failure to deploy 14
Detachment of device or device component 13
Device operates differently than expected 13
Other (for use when an appropriate device code cannot be identified) 12
Entrapment of device or device component 12
Material separation 12
Detachment of device component 12
Device damaged prior to use 11
Split 11
Torn material 11
Unintended movement 10
Delivery system failure 9
Material rupture 9
Malposition of device 9
Improper or incorrect procedure or method 9
Unknown (for use when the device problem is not known) 9
Physical resistance 8
Difficult to advance 8
Device markings issue 7
Sticking 7
Material Distortion 6
Difficult to insert 5
Crack 5
Unsealed device packaging 5
Device, or device fragments remain in patient 5
Tip breakage 5
Not Applicable 5
No code available 4
Unstable 4
Interference 4
Loose 4
Incorrect or inadequate result 4
Device expiration issue 4
No Information 4
Kinked 4
Packaging issue 3
Resistance, inadequate 3
Failure to deliver 3
Deflation issue 3
Balloon rupture 2
Inflation issue 2
Failure to Adhere or Bond 2
Defective component 2
Tear, rip or hole in device packaging 2
Shaft break 2
Therapy delivered to incorrect body area 2
Device, removal of (non-implant) 2
Foreign material present in device 2
Hole in material 2
Device or device component damaged by another device 2
Mechanical jam 2
Defective item 2
Loose or intermittent connection 2
Insufficient flow or underinfusion 1
Balloon pinhole 1
Positioning Issue 1
Displacement 1
Device or device fragments location unknown 1
Material perforation 1
Instruction for use issue 1
Slippage of device or device component 1
Dissection 1
Collapse 1
Material fragmentation 1
Catheter withdrawal interference 1
Folded 1
Misplacement 1
Leak 1
Application interface becomes non-functional or program exits abnormally 1
Incompatibility problem 1
Foreign material 1
Sterility 1
Tears, rips, holes in device, device material 1
Patient-device incompatibility 1
Material twisted 1
Balloon burst 1
Mislabeled 1
Device Difficult to Setup or Prepare 1
Use of Device Issue 1
Tipover 1
Component missing 1
Total Device Problems 1184

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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