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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 4

Device Problems
Premature deployment 133
Dislodged or dislocated 130
No Known Device Problem 114
Deployment issue 101
Difficult to remove 73
Difficult to deploy 69
Inaccurate delivery 61
Occlusion within device 56
Fracture 38
Migration of device or device component 37
Failure to advance 31
Detachment of device or device component 30
Failure to deploy 30
Bent 29
Break 23
Material frayed 23
Difficult to position 23
Device damaged prior to use 20
Material deformation 20
Detachment of device component 18
Dislodged 17
Entrapment of device or device component 17
Device remains implanted 17
Size incorrect for patient 14
Torn material 14
Device operates differently than expected 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
Tip breakage 5
Device, or device fragments remain in patient 5
Loose 4
Incorrect or inadequate result 4
Unstable 4
Defective component 4
Interference 4
No Information 4
No code available 4
Foreign material present in device 3
Packaging issue 3
Failure to deliver 3
Hole in material 3
Failure to Adhere or Bond 3
Therapy delivered to incorrect body area 3
Resistance, inadequate 3
Shaft break 2
Tear, rip or hole in device packaging 2
Defective item 2
Balloon rupture 2
Inflation issue 2
Leak 2
Loose or intermittent connection 2
Device, removal of (non-implant) 2
Device or device component damaged by another device 2
Positioning Issue 2
Mechanical jam 2
No flow 1
Incompatibility problem 1
Material Protrusion 1
Material twisted 1
Balloon pinhole 1
Catheter withdrawal interference 1
Failure to separate 1
Folded 1
Patient-device incompatibility 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
Tipover 1
Device or device fragments location unknown 1
Component missing 1
Use of Device Issue 1
Total Device Problems 1428

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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