• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 10

Device Problems
Dislodged or dislocated 140
Premature deployment 139
No Known Device Problem 127
Deployment issue 109
Difficult to remove 76
Difficult to deploy 73
Inaccurate delivery 62
Occlusion within device 56
Failure to advance 40
Migration of device or device component 39
Fracture 39
Failure to deploy 37
Detachment of device or device component 37
Bent 33
Material frayed 28
Break 24
Difficult to position 24
Device damaged prior to use 21
Material deformation 20
Detachment of device component 19
Entrapment of device or device component 19
Dislodged 17
Device remains implanted 17
Torn material 16
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
Physical resistance 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
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
Inflation issue 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
Balloon rupture 2
Burst 2
Loose or intermittent connection 2
Device or device component damaged by another device 2
Defective item 2
Device, removal of (non-implant) 2
Positioning Issue 2
Mechanical jam 2
No flow 1
Material Protrusion 1
Material twisted 1
Balloon pinhole 1
Catheter withdrawal interference 1
Folded 1
Patient-device incompatibility 1
Tipover 1
Device or device fragments location unknown 1
Incompatibility problem 1
Mislabeled 1
Misplacement 1
Delivered as unsterile product 1
Material fragmentation 1
Instruction for use issue 1
Collapse 1
Application interface becomes non-functional or program exits abnormally 1
Balloon burst 1
Bleed back 1
Failure to flush 1
Foreign material 1
Displacement 1
Dissection 1
Total Device Problems 1532

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

-
-