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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 5

Device Problems
Dislodged 1232
Failure to advance 1084
Device damaged prior to use 548
Other (for use when an appropriate device code cannot be identified) 506
Occlusion within device 477
Dislodged or dislocated 443
Unknown (for use when the device problem is not known) 421
Device remains implanted 417
Balloon rupture 416
Use of Device Issue 386
Bent 322
Difficult to remove 268
No Known Device Problem 262
Loose 138
Leak 121
Material deformation 117
Shaft break 102
Break 85
Deflation issue 85
Detachment of device component 79
Source, detachment from 76
Improper or incorrect procedure or method 73
Not Applicable 57
Fracture 55
Difficult to deploy 53
Inflation issue 50
Kinked 47
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 36
Material rupture 35
Component missing 34
Failure to deliver 32
Failure to deploy 25
Entrapment of device or device component 19
Deployment issue 18
Detachment of device or device component 17
Premature deployment 16
Slippage of device or device component 15
Peeled 12
Unstable 12
Unintended movement 12
Malposition of device 12
Device expiration issue 11
Foreign material 11
Balloon burst 11
Mislabeled 10
Device or device component damaged by another device 10
Difficult to advance 10
No Information 9
Material separation 9
Balloon leak(s) 9
Dissection 9
Burst 8
Material Distortion 8
Device, removal of (non-implant) 7
Defective item 7
Malfunction 7
Crack 7
Size incorrect for patient 7
Unsealed device packaging 7
Device Issue 6
Tears, rips, holes in device, device material 6
Foreign material present in device 6
Tip breakage 5
Sticking 5
Mislocation 5
Explanted 5
Collapse 5
Displacement 4
Method, improper/incorrect 4
Stretched 4
Device or device fragments location unknown 4
Tear, rip or hole in device packaging 3
Out-of-box failure 3
Strut fracture 3
Sterility 3
Device markings issue 3
Incorrect measurement 3
Misapplication 3
Blockage within device or device component 3
Component(s), broken 2
Loose or intermittent connection 2
Reaction 2
Difficult to open or remove packaging material 2
Inaccurate delivery 2
Material perforation 2
Seal, defective 2
Obstruction within device 2
Patch test, abnormal results of 1
pH, low 1
Cut in material 1
Failure to separate 1
Balloon pinhole 1
Catheter withdrawal interference 1
Folded 1
Component or accessory incompatibility 1
Underdelivery 1
Total Device Problems 8660

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 0
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

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