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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 21

Device Problems
Premature deployment 132
Dislodged or dislocated 125
No Known Device Problem 113
Deployment issue 98
Difficult to remove 69
Difficult to deploy 64
Inaccurate delivery 61
Occlusion within device 56
Fracture 38
Migration of device or device component 34
Failure to advance 30
Detachment of device or device component 28
Bent 28
Failure to deploy 25
Difficult to position 23
Material frayed 22
Break 21
Material deformation 19
Device damaged prior to use 18
Device remains implanted 17
Detachment of device component 17
Dislodged 17
Entrapment of device or device component 15
Size incorrect for patient 14
Device operates differently than expected 13
Torn material 13
Material separation 12
Other (for use when an appropriate device code cannot be identified) 12
Device expiration issue 12
Split 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
Deflation issue 7
Material Distortion 6
Not Applicable 5
Difficult to insert 5
Unsealed device packaging 5
Kinked 5
Crack 5
Device, or device fragments remain in patient 5
Tip breakage 5
Unstable 4
Defective component 4
Loose 4
Incorrect or inadequate result 4
Interference 4
No Information 4
No code available 4
Foreign material present in device 3
Packaging issue 3
Hole in material 3
Failure to Adhere or Bond 3
Resistance, inadequate 3
Failure to deliver 3
Tear, rip or hole in device packaging 2
Defective item 2
Therapy delivered to incorrect body area 2
Shaft break 2
Balloon rupture 2
Inflation issue 2
Leak 2
Loose or intermittent connection 2
Positioning Issue 2
Mechanical jam 2
Device or device component damaged by another device 2
Device, removal of (non-implant) 2
Balloon pinhole 1
Catheter withdrawal interference 1
Failure to separate 1
Folded 1
Patient-device incompatibility 1
Material Protrusion 1
Material twisted 1
No flow 1
Incompatibility problem 1
Mislabeled 1
Misplacement 1
Delivered as unsterile product 1
Material fragmentation 1
Instruction for use issue 1
Balloon burst 1
Bleed back 1
Application interface becomes non-functional or program exits abnormally 1
Collapse 1
Failure to flush 1
Foreign material 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
Total Device Problems 1386

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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