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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 1

Device Problems
Occlusion within device 7418
Failure to advance 5212
No Known Device Problem 5005
Device remains implanted 4524
Bent 3708
Device damaged prior to use 2933
Unknown (for use when the device problem is not known) 2750
Dislodged or dislocated 2074
Dislodged 1448
Difficult to remove 1287
Not Applicable 1072
Material deformation 695
Fracture 640
Other (for use when an appropriate device code cannot be identified) 599
Use of Device Issue 563
Break 522
Shaft break 471
Crack 443
Kinked 414
Device or device component damaged by another device 372
Deployment issue 324
Inflation issue 308
Dissection 300
Failure to deliver 274
Improper or incorrect procedure or method 270
Leak 244
Detachment of device component 238
Balloon rupture 197
Migration of device or device component 197
Difficult to deploy 187
Device, or device fragments remain in patient 181
Deflation issue 174
Burst 165
Loose 158
Material rupture 143
Balloon burst 137
Difficult to insert 134
Underdelivery 133
Difficult to position 128
Malposition of device 116
Entrapment of device or device component 101
Physical resistance 93
Material separation 90
Source, detachment from 86
Failure to deploy 84
Inaccurate delivery 70
Difficult to advance 69
Balloon leak(s) 68
Slippage of device or device component 66
Device expiration issue 60
Strut fracture 54
No Information 50
Device or device fragments location unknown 50
Stretched 47
Blockage within device or device component 37
Unintended movement 34
Detachment of device or device component 33
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
Device markings issue 11
Torn material 11
Tears, rips, holes in device, device material 10
Component missing 10
Implant, removal of 9
Defective component 9
Insufficient flow or underinfusion 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 47878

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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