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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 2017
3 4 7 14 23 34 47 33 27 22 0

Device Problems
Premature deployment 132
Dislodged or dislocated 128
No Known Device Problem 114
Deployment issue 99
Difficult to remove 71
Difficult to deploy 68
Inaccurate delivery 61
Occlusion within device 56
Fracture 38
Migration of device or device component 35
Failure to advance 30
Bent 29
Detachment of device or device component 29
Failure to deploy 28
Difficult to position 23
Break 22
Material frayed 22
Material deformation 20
Device damaged prior to use 19
Detachment of device component 18
Dislodged 17
Device remains implanted 17
Entrapment of device or device component 16
Size incorrect for patient 14
Torn material 13
Device operates differently than expected 13
Other (for use when an appropriate device code cannot be identified) 12
Device expiration issue 12
Material separation 12
Split 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
Deflation issue 7
Material Distortion 6
Difficult to insert 5
Kinked 5
Crack 5
Unsealed device packaging 5
Not Applicable 5
Device, or device fragments remain in patient 5
Tip breakage 5
Unstable 4
Defective component 4
Interference 4
No code available 4
Loose 4
Incorrect or inadequate result 4
No Information 4
Packaging issue 3
Resistance, inadequate 3
Foreign material present in device 3
Hole in material 3
Failure to deliver 3
Failure to Adhere or Bond 3
Tear, rip or hole in device packaging 2
Inflation issue 2
Balloon rupture 2
Mechanical jam 2
Device or device component damaged by another device 2
Device, removal of (non-implant) 2
Leak 2
Shaft break 2
Therapy delivered to incorrect body area 2
Defective item 2
Loose or intermittent connection 2
Positioning Issue 2
Displacement 1
Balloon pinhole 1
Insufficient flow or underinfusion 1
Dissection 1
Material perforation 1
Instruction for use issue 1
Slippage of device or device component 1
Failure to flush 1
Collapse 1
Device or device fragments location unknown 1
Misplacement 1
Catheter withdrawal interference 1
Material Protrusion 1
Material fragmentation 1
Failure to separate 1
Folded 1
No flow 1
Mislabeled 1
Balloon burst 1
Use of Device Issue 1
Component missing 1
Tipover 1
Device Difficult to Setup or Prepare 1
Bleed back 1
Delivered as unsterile product 1
Tears, rips, holes in device, device material 1
Total Device Problems 1408

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 0 0 2 0 0 0 1 0
Class III 0 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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