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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 2017
23 59 88 82 97 167 99 128 45 72 2

Device Problems
Occlusion within device 7459
Failure to advance 5298
No Known Device Problem 5082
Device remains implanted 4524
Bent 3792
Device damaged prior to use 2967
Unknown (for use when the device problem is not known) 2750
Dislodged or dislocated 2149
Dislodged 1448
Difficult to remove 1294
Not Applicable 1072
Material deformation 719
Fracture 647
Other (for use when an appropriate device code cannot be identified) 599
Use of Device Issue 563
Break 544
Shaft break 471
Crack 443
Kinked 421
Device or device component damaged by another device 382
Deployment issue 335
Inflation issue 311
Dissection 300
Failure to deliver 274
Improper or incorrect procedure or method 270
Leak 245
Detachment of device component 239
Migration of device or device component 198
Balloon rupture 197
Difficult to deploy 187
Device, or device fragments remain in patient 181
Deflation issue 176
Burst 168
Loose 158
Material rupture 145
Balloon burst 137
Difficult to insert 134
Underdelivery 133
Difficult to position 129
Malposition of device 117
Entrapment of device or device component 105
Physical resistance 94
Material separation 90
Source, detachment from 86
Failure to deploy 84
Difficult to advance 73
Inaccurate delivery 71
Balloon leak(s) 68
Slippage of device or device component 66
Device expiration issue 60
Strut fracture 54
Device or device fragments location unknown 51
No Information 50
Stretched 48
Blockage within device or device component 37
Detachment of device or device component 35
Unintended movement 34
Misapplication 32
Foreign material 29
Out-of-box failure 29
Foreign material present in device 29
Size incorrect for patient 26
Premature deployment 23
Explanted 23
Material Distortion 22
No code available 20
Hole in material 18
Interference 18
Unstable 18
Device, removal of (non-implant) 17
Positioning Issue 16
Material perforation 16
Misplacement 16
Balloon pinhole 14
Material opacification 13
Component(s), broken 13
Defective item 13
Obstruction within device 12
Reaction 12
Tip breakage 12
Unsealed device packaging 12
Mislabeled 12
Peeled 11
Material frayed 11
Sticking 11
Component missing 11
Device markings issue 11
Torn material 11
Tears, rips, holes in device, device material 10
Insufficient flow or underinfusion 9
Implant, removal of 9
Defective component 9
Fluid leak 9
Displacement 9
Restricted flowrate 8
Delivery system failure 8
Device operates differently than expected 8
Device packaging compromised 7
Collapse 6
Tracking 6
Total Device Problems 48393

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