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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
24 19 12 14 17 23 14 2 11 2

Device Problems
Unknown (for use when the device problem is not known) 1073
No Known Device Problem 850
Other (for use when an appropriate device code cannot be identified) 377
Device remains implanted 231
Occlusion within device 224
Inaccurate delivery 145
Break 95
Premature deployment 78
Migration of device or device component 63
Failure to deploy 60
Difficult to remove 55
Difficult to deploy 52
No Information 50
No code available 42
Detachment of device component 39
Device damaged prior to use 35
Deployment issue 31
Source, detachment from 27
Bent 23
Physical resistance 19
Failure to advance 18
Use of Device Issue 17
Difficult to position 16
Fracture 15
Shaft break 14
Kinked 13
Retraction problem 10
Material separation 9
Device expiration issue 8
Component(s), broken 7
Entrapment of device or device component 7
Tip breakage 7
Improper or incorrect procedure or method 6
Dislodged or dislocated 6
Difficult to flush 6
Crack 6
Difficult to insert 5
Size incorrect for patient 5
Dislodged 5
Leak 4
Material deformation 4
Malposition of device 4
Positioning Issue 4
Interference 4
Foreign material 3
Delivery System Issue, No Description 3
Mislabeled 3
Locking mechanism failure 3
Collapse 3
Split 3
Detachment of device or device component 3
Foreign material present in device 3
Sticking 3
Method, improper/incorrect 3
Visibility/palpability 3
Device clogged 2
Device Issue 2
Misplacement 2
Blockage within device or device component 2
Unintended movement 2
Torn material 2
Defective item 2
Failure to flush 2
Underdelivery 2
Material frayed 2
Failure to deliver 2
Obstruction within device 2
Explanted 2
Balloon rupture 2
Device, or device fragments remain in patient 2
Tears, rips, holes in device, device material 2
Bubble(s) 2
Motor failure 1
Wrinkled 1
Balloon burst 1
No display or display failure 1
Incorrect measurement 1
Structural problem 1
Buckled material 1
Strut fracture 1
Component missing 1
Bleed back 1
High Readings 1
Insufficient flow or underinfusion 1
Displacement 1
Difficult to advance 1
Nonstandard device or device component 1
Delivery system failure 1
Stretched 1
Material perforation 1
Implant, removal of 1
Packaging issue 1
Device misassembled during manufacturing or shipping 1
Device-device incompatibility 1
Folded 1
Device packaging compromised 1
Out-of-box failure 1
Total Device Problems 3861

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 1 0 0 0 0 0 0 0 0
Class II 1 1 0 3 0 0 0 1 0 0
Class III 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 Ev3, Inc. II Dec-29-2014

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