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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device coronary drug-eluting stent
Definition Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
Product CodeNIQ
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
23 59 88 82 97 167 99 128 45 37

Device Problems
Occlusion within device 7193
Failure to advance 4838
No Known Device Problem 4628
Device remains implanted 4522
Bent 2975
Unknown (for use when the device problem is not known) 2750
Device damaged prior to use 2657
Dislodged or dislocated 1527
Dislodged 1448
Difficult to remove 1228
Not Applicable 1072
Other (for use when an appropriate device code cannot be identified) 599
Fracture 597
Use of Device Issue 563
Material deformation 544
Shaft break 471
Crack 443
Break 428
Kinked 403
Dissection 300
Inflation issue 294
Deployment issue 277
Failure to deliver 274
Improper or incorrect procedure or method 269
Device or device component damaged by another device 265
Detachment of device component 236
Leak 232
Balloon rupture 197
Difficult to deploy 182
Device, or device fragments remain in patient 181
Migration of device or device component 179
Deflation issue 160
Burst 159
Loose 158
Balloon burst 137
Underdelivery 133
Difficult to insert 132
Material rupture 126
Difficult to position 113
Malposition of device 112
Physical resistance 93
Material separation 90
Source, detachment from 86
Failure to deploy 83
Entrapment of device or device component 76
Balloon leak(s) 68
Inaccurate delivery 67
Slippage of device or device component 66
Difficult to advance 62
Strut fracture 54
No Information 50
Device or device fragments location unknown 45
Blockage within device or device component 37
Stretched 34
Misapplication 32
Unintended movement 32
Device expiration issue 29
Foreign material 29
Out-of-box failure 29
Size incorrect for patient 26
Foreign material present in device 26
Detachment of device or device component 23
Explanted 23
Premature deployment 21
Material Distortion 21
No code available 20
Interference 18
Unstable 18
Device, removal of (non-implant) 17
Material perforation 16
Hole in material 16
Misplacement 16
Positioning Issue 15
Balloon pinhole 14
Material opacification 13
Component(s), broken 13
Unsealed device packaging 12
Mislabeled 12
Obstruction within device 12
Reaction 12
Tip breakage 12
Sticking 11
Peeled 11
Material frayed 11
Device markings issue 11
Torn material 11
Tears, rips, holes in device, device material 10
Insufficient flow or underinfusion 9
Defective item 9
Implant, removal of 9
Component missing 9
Fluid leak 9
Displacement 9
Restricted flowrate 8
Defective component 8
Delivery system failure 8
Device operates differently than expected 7
Device packaging compromised 7
Tracking 6
Port leak(s) 6
Total Device Problems 44609

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

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Vascular Galway Limited II Aug-21-2009
2 Medtronic Vascular, Inc. II Nov-05-2013

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