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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 8

Device Problems
Unknown (for use when the device problem is not known) 1073
No Known Device Problem 864
Other (for use when an appropriate device code cannot be identified) 377
Device remains implanted 231
Occlusion within device 226
Inaccurate delivery 145
Break 96
Premature deployment 80
Migration of device or device component 63
Failure to deploy 60
Difficult to deploy 58
Difficult to remove 56
No Information 52
No code available 42
Detachment of device component 41
Deployment issue 39
Device damaged prior to use 38
Source, detachment from 27
Bent 26
Failure to advance 20
Physical resistance 19
Use of Device Issue 17
Difficult to position 16
Fracture 15
Shaft break 14
Kinked 13
Retraction problem 10
Material deformation 10
Dislodged or dislocated 9
Material separation 9
Entrapment of device or device component 8
Device expiration issue 8
Crack 7
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
Interference 4
Leak 4
Malposition of device 4
Positioning Issue 4
Visibility/palpability 3
Locking mechanism failure 3
Foreign material present in device 3
Detachment of device or device component 3
Delivery System Issue, No Description 3
Mislabeled 3
Foreign material 3
Collapse 3
Split 3
Sticking 3
Method, improper/incorrect 3
Device, or device fragments remain in patient 2
Tears, rips, holes in device, device material 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
Material frayed 2
Failure to flush 2
Explanted 2
Misplacement 2
Device packaging compromised 2
Defective item 2
Failure to deliver 2
Torn material 2
Unintended movement 2
Material Distortion 1
Packaging issue 1
Folded 1
Wrinkled 1
Device-device incompatibility 1
Difficult to advance 1
Buckled material 1
Delivery system failure 1
Device misassembled during manufacturing or shipping 1
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
Material perforation 1
Insufficient flow or underinfusion 1
Component missing 1
Out-of-box failure 1
Implant, removal of 1
Shelf life exceeded 1
Stretched 1
Strut fracture 1
Total Device Problems 3924

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 1
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 Cordis Corporation II Jun-10-2016
8 Ev3, Inc. II Dec-29-2014

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