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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 18

Device Problems
Premature deployment 128
Dislodged or dislocated 120
No Known Device Problem 94
Deployment issue 93
Difficult to remove 64
Inaccurate delivery 61
Difficult to deploy 57
Occlusion within device 52
Fracture 38
Migration of device or device component 30
Failure to advance 29
Bent 24
Detachment of device or device component 24
Difficult to position 23
Material frayed 22
Break 20
Material deformation 19
Dislodged 17
Device remains implanted 17
Failure to deploy 16
Detachment of device component 16
Entrapment of device or device component 14
Size incorrect for patient 14
Device damaged prior to use 14
Device operates differently than expected 13
Torn material 13
Other (for use when an appropriate device code cannot be identified) 12
Material separation 12
Split 11
Unintended movement 10
Delivery system failure 9
Malposition of device 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
Device expiration issue 7
Deflation issue 6
Material Distortion 6
Not Applicable 5
Kinked 5
Difficult to insert 5
Unsealed device packaging 5
Crack 5
Device, or device fragments remain in patient 5
Tip breakage 5
Unstable 4
Incorrect or inadequate result 4
Loose 4
Interference 4
No Information 4
No code available 4
Packaging issue 3
Failure to deliver 3
Hole in material 3
Failure to Adhere or Bond 3
Resistance, inadequate 3
Defective component 3
Defective item 2
Tear, rip or hole in device packaging 2
Therapy delivered to incorrect body area 2
Shaft break 2
Balloon rupture 2
Inflation issue 2
Loose or intermittent connection 2
Device, removal of (non-implant) 2
Mechanical jam 2
Device or device component damaged by another device 2
Foreign material present in device 2
Positioning Issue 2
Incompatibility problem 1
No flow 1
Material twisted 1
Balloon pinhole 1
Catheter withdrawal interference 1
Folded 1
Patient-device incompatibility 1
Mislabeled 1
Misplacement 1
Delivered as unsterile product 1
Instruction for use issue 1
Leak 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
Tears, rips, holes in device, device material 1
Slippage of device or device component 1
Sterility 1
Device Difficult to Setup or Prepare 1
Failure to separate 1
Tipover 1
Device or device fragments location unknown 1
Total Device Problems 1299

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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