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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 8

Device Problems
Premature deployment 134
Dislodged or dislocated 132
No Known Device Problem 123
Deployment issue 104
Difficult to remove 75
Difficult to deploy 72
Inaccurate delivery 62
Occlusion within device 56
Migration of device or device component 39
Fracture 39
Failure to deploy 35
Failure to advance 34
Detachment of device or device component 32
Bent 30
Material frayed 27
Difficult to position 24
Break 23
Device damaged prior to use 20
Material deformation 20
Detachment of device component 19
Entrapment of device or device component 18
Dislodged 17
Device remains implanted 17
Torn material 15
Device operates differently than expected 14
Size incorrect for patient 14
Device expiration issue 13
Material separation 12
Other (for use when an appropriate device code cannot be identified) 12
Split 11
Malposition of device 11
Unintended movement 10
Difficult to advance 10
Delivery system failure 9
Unknown (for use when the device problem is not known) 9
Improper or incorrect procedure or method 9
Physical resistance 9
Material rupture 9
Device markings issue 8
Sticking 7
Deflation issue 7
Material Distortion 6
Not Applicable 5
Foreign material present in device 5
Difficult to insert 5
Unsealed device packaging 5
Kinked 5
Crack 5
Tip breakage 5
Defective component 5
Device, or device fragments remain in patient 5
Loose 4
Incorrect or inadequate result 4
Unstable 4
Interference 4
No Information 4
No code available 4
Packaging issue 3
Failure to deliver 3
Hole in material 3
Leak 3
Failure to Adhere or Bond 3
Therapy delivered to incorrect body area 3
Resistance, inadequate 3
Shaft break 2
Use of Device Issue 2
Material perforation 2
Tear, rip or hole in device packaging 2
Defective item 2
Balloon rupture 2
Loose or intermittent connection 2
Inflation issue 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
Material fragmentation 1
Instruction for use issue 1
Mislabeled 1
Misplacement 1
Delivered as unsterile product 1
Balloon burst 1
Bleed back 1
Application interface becomes non-functional or program exits abnormally 1
Burst 1
Collapse 1
Failure to flush 1
Foreign material 1
Displacement 1
Dissection 1
Tipover 1
Total Device Problems 1485

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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