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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 2014 2015 2016 2017
24 19 12 14 17 23 14 2 11 11 4

Device Problems
Unknown (for use when the device problem is not known) 1073
No Known Device Problem 876
Other (for use when an appropriate device code cannot be identified) 377
Device remains implanted 231
Occlusion within device 226
Inaccurate delivery 145
Break 97
Premature deployment 80
Difficult to deploy 65
Migration of device or device component 65
Failure to deploy 62
Difficult to remove 59
No Information 52
Deployment issue 48
Detachment of device component 45
No code available 42
Device damaged prior to use 41
Source, detachment from 27
Bent 27
Failure to advance 20
Physical resistance 19
Use of Device Issue 17
Difficult to position 16
Fracture 16
Shaft break 14
Kinked 13
Material deformation 12
Dislodged or dislocated 10
Retraction problem 10
Material separation 9
Entrapment of device or device component 9
Device expiration issue 8
Crack 8
Component(s), broken 7
Size incorrect for patient 7
Tip breakage 7
Improper or incorrect procedure or method 6
Difficult to flush 6
Difficult to insert 5
Dislodged 5
Positioning Issue 5
Detachment of device or device component 4
Malposition of device 4
Interference 4
Leak 4
Foreign material 3
Method, improper/incorrect 3
Mislabeled 3
Collapse 3
Split 3
Sticking 3
Delivery System Issue, No Description 3
Locking mechanism failure 3
Foreign material present in device 3
Visibility/palpability 3
Difficult to advance 2
Device packaging compromised 2
Defective item 2
Torn material 2
Unintended movement 2
Tears, rips, holes in device, device material 2
Device, or device fragments remain in patient 2
Failure to deliver 2
Underdelivery 2
Device Issue 2
Obstruction within device 2
Balloon rupture 2
Bubble(s) 2
Device clogged 2
Blockage within device or device component 2
Misplacement 2
Material frayed 2
Failure to flush 2
Explanted 2
Motor failure 1
Nonstandard device or device component 1
Incorrect measurement 1
Failure to Adhere or Bond 1
Balloon burst 1
Bleed back 1
Displacement 1
No display or display failure 1
High Readings 1
Structural problem 1
Insufficient flow or underinfusion 1
Material perforation 1
Component missing 1
Out-of-box failure 1
Implant, removal of 1
Shelf life exceeded 1
Stretched 1
Strut fracture 1
Material Distortion 1
Packaging issue 1
Wrinkled 1
Buckled material 1
Delivery system failure 1
Folded 1
Device-device incompatibility 1
Device misassembled during manufacturing or shipping 1
Total Device Problems 3977

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 1 0 0 0 0 0 0 0 0 0
Class II 1 1 0 3 0 0 0 1 0 1 0
Class III 0 0 0 0 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
7 Cordis Corporation II Jun-10-2016
8 Ev3, Inc. II Dec-29-2014

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