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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stent, coronary
Definition The formerly known device, Cardiovascular Stent, coded as "MAF" has been modified and is currently known and classified as a "Coronary Stent". This device is a metal scaffold placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.
Product CodeMAF
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
34 42 37 56 70 86 53 55 24 32 32

Device Problems
Dislodged 1232
Failure to advance 1101
Device damaged prior to use 568
Other (for use when an appropriate device code cannot be identified) 506
Occlusion within device 483
Dislodged or dislocated 477
Unknown (for use when the device problem is not known) 421
Device remains implanted 417
Balloon rupture 416
Use of Device Issue 386
Bent 375
No Known Device Problem 289
Difficult to remove 270
Loose 138
Material deformation 128
Leak 125
Shaft break 102
Break 91
Deflation issue 85
Detachment of device component 79
Source, detachment from 76
Improper or incorrect procedure or method 74
Not Applicable 57
Fracture 55
Difficult to deploy 53
Inflation issue 51
Kinked 49
Device, or device fragments remain in patient 47
Difficult to position 47
Physical resistance 46
Difficult to insert 40
Migration of device or device component 37
Material rupture 36
Failure to deliver 35
Component missing 35
Failure to deploy 27
Entrapment of device or device component 22
Deployment issue 21
Detachment of device or device component 21
No Information 17
Premature deployment 16
Device or device component damaged by another device 15
Slippage of device or device component 15
Difficult to advance 14
Device expiration issue 14
Peeled 13
Malposition of device 13
Unintended movement 12
Unstable 12
Foreign material 11
Balloon burst 11
Burst 10
Mislabeled 10
Material separation 9
Balloon leak(s) 9
Dissection 9
Unsealed device packaging 8
Malfunction 8
Material Distortion 8
Defective item 7
Device, removal of (non-implant) 7
Size incorrect for patient 7
Crack 7
Device Issue 6
Tears, rips, holes in device, device material 6
Foreign material present in device 6
Tip breakage 5
Sticking 5
Explanted 5
Collapse 5
Mislocation 5
Method, improper/incorrect 4
Displacement 4
Stretched 4
Device or device fragments location unknown 4
Device markings issue 4
Tear, rip or hole in device packaging 3
Strut fracture 3
Sterility 3
Out-of-box failure 3
Blockage within device or device component 3
Incorrect measurement 3
Misapplication 3
Reaction 2
Component(s), broken 2
Loose or intermittent connection 2
Seal, defective 2
Material perforation 2
Obstruction within device 2
Inaccurate delivery 2
Difficult to open or remove packaging material 2
Device packaging compromised 2
Expulsion 2
Failure to unwrap 1
Positioning Issue 1
No code available 1
Material Protrusion 1
Material twisted 1
Device operates differently than expected 1
Folded 1
Total Device Problems 8891

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 1 0 0 0 0 0 0 0 0
Class II 1 0 2 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular-Cardiac Therapies dba Guidant Corporation I Jul-29-2009
2 Abbott Vascular-Cardiac Therapies dba Guidant Corporation II Feb-03-2009
3 Abbott Vascular-Cardiac Therapies dba Guidant Corporation II Aug-29-2007
4 Boston Scientific Corporation II Oct-21-2009
5 Cordis Corporation II Apr-15-2017

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