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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stent, carotid
Definition Stent, Carotid -- a metal scaffold placed via a delivery catheter into the carotid artery to maintain the lumen
Product CodeNIM
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013
24 19 12 14 17 23 5

Device Problems
Unknown (for use when the device problem is not known) 1073
No Known Device Problem 828
Other (for use when an appropriate device code cannot be identified) 377
Device remains implanted 231
Occlusion within device 223
Inaccurate delivery 144
Break 91
Premature deployment 73
Migration of device or device component 62
Failure to deploy 58
Difficult to remove 49
No Information 49
No code available 42
Difficult to deploy 37
Device damaged prior to use 35
Source, detachment from 27
Deployment issue 26
Detachment of device component 26
Physical resistance 19
Bent 17
Use of Device Issue 17
Difficult to position 16
Failure to advance 16
Shaft break 14
Fracture 13
Kinked 11
Material separation 9
Retraction problem 9
Device expiration issue 8
Component(s), broken 7
Tip breakage 7
Improper or incorrect procedure or method 6
Dislodged 5
Difficult to insert 5
Difficult to flush 5
Dislodged or dislocated 4
Interference 4
Malposition of device 4
Positioning Issue 4
Leak 4
Size incorrect for patient 4
Locking mechanism failure 3
Entrapment of device or device component 3
Method, improper/incorrect 3
Foreign material 3
Visibility/palpability 3
Delivery System Issue, No Description 3
Detachment of device or device component 3
Mislabeled 3
Split 3
Defective item 2
Obstruction within device 2
Failure to flush 2
Explanted 2
Balloon rupture 2
Crack 2
Collapse 2
Failure to deliver 2
Device Issue 2
Device clogged 2
Tears, rips, holes in device, device material 2
Device, or device fragments remain in patient 2
Underdelivery 2
Sticking 2
Blockage within device or device component 2
Bubble(s) 2
Misplacement 2
Foreign material present in device 2
Material deformation 2
Unintended movement 2
Device misassembled during manufacturing or shipping 1
High Readings 1
Insufficient flow or underinfusion 1
Difficult to advance 1
Material frayed 1
Bleed back 1
Displacement 1
Wrinkled 1
Out-of-box failure 1
Motor failure 1
Device packaging compromised 1
Packaging issue 1
Torn material 1
No display or display failure 1
Balloon burst 1
Incorrect measurement 1
Nonstandard device or device component 1
Structural problem 1
Buckled material 1
Delivery system failure 1
Stretched 1
Strut fracture 1
Material perforation 1
Component missing 1
Implant, removal of 1
Total Device Problems 3751

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 1 0 0 0 0 0
Class II 1 1 0 3 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Nov-10-2010
2 Abbott Vascular-Cardiac Therapies dba Guidant Corporation II Mar-16-2010
3 Abbott Vascular-Cardiac Therapies dba Guidant Corporation II Jan-29-2010
4 Boston Scientific Corporation I Aug-13-2008
5 Boston Scientific Corporation II Aug-09-2007
6 Boston Scientific Cupertino, Corporation II Sep-16-2008

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