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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 10

Device Problems
Premature deployment 126
Dislodged or dislocated 111
No Known Device Problem 92
Deployment issue 90
Inaccurate delivery 60
Difficult to remove 58
Difficult to deploy 55
Occlusion within device 50
Fracture 36
Failure to advance 29
Migration of device or device component 28
Difficult to position 23
Bent 22
Break 19
Material frayed 19
Detachment of device or device component 18
Dislodged 17
Device remains implanted 17
Material deformation 16
Size incorrect for patient 14
Failure to deploy 14
Detachment of device component 14
Entrapment of device or device component 13
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
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
Device expiration issue 6
Material Distortion 6
Not Applicable 5
Crack 5
Difficult to insert 5
Kinked 5
Unsealed device packaging 5
Device, or device fragments remain in patient 5
Tip breakage 5
Unstable 4
Incorrect or inadequate result 4
Loose 4
Deflation issue 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
Device, removal of (non-implant) 2
Therapy delivered to incorrect body area 2
Shaft break 2
Balloon rupture 2
Inflation issue 2
Loose or intermittent connection 2
Device or device component damaged by another device 2
Positioning Issue 2
Mechanical jam 2
Foreign material present in device 2
Incompatibility problem 1
Material twisted 1
No flow 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
Balloon pinhole 1
Catheter withdrawal interference 1
Tipover 1
Device or device fragments location unknown 1
Component missing 1
Total Device Problems 1241

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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