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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 20

Device Problems
Occlusion within device 7626
Failure to advance 5593
No Known Device Problem 5416
Device remains implanted 4524
Bent 4293
Device damaged prior to use 3134
Unknown (for use when the device problem is not known) 2750
Dislodged or dislocated 2474
Dislodged 1448
Difficult to remove 1350
Not Applicable 1072
Material deformation 797
Fracture 671
Break 645
Other (for use when an appropriate device code cannot be identified) 599
Use of Device Issue 563
Shaft break 471
Crack 444
Kinked 443
Device or device component damaged by another device 425
Deployment issue 371
Inflation issue 315
Dissection 300
Failure to deliver 274
Improper or incorrect procedure or method 270
Leak 251
Detachment of device component 242
Migration of device or device component 205
Balloon rupture 197
Difficult to deploy 188
Deflation issue 187
Device, or device fragments remain in patient 181
Burst 172
Loose 158
Material rupture 152
Balloon burst 137
Difficult to insert 136
Underdelivery 133
Difficult to position 130
Entrapment of device or device component 120
Malposition of device 120
Physical resistance 94
Material separation 90
Source, detachment from 86
Failure to deploy 84
Difficult to advance 78
Inaccurate delivery 72
Balloon leak(s) 68
Device expiration issue 67
Slippage of device or device component 66
Strut fracture 54
Stretched 53
Device or device fragments location unknown 53
No Information 50
Detachment of device or device component 43
Blockage within device or device component 37
Foreign material present in device 35
Unintended movement 35
Misapplication 32
Foreign material 29
Out-of-box failure 29
Size incorrect for patient 27
Premature deployment 24
Explanted 23
Material Distortion 22
No code available 20
Hole in material 20
Interference 18
Unstable 18
Device, removal of (non-implant) 17
Positioning Issue 16
Material perforation 16
Misplacement 16
Defective item 15
Balloon pinhole 14
Device markings issue 14
Material opacification 13
Component(s), broken 13
Unsealed device packaging 12
Peeled 12
Mislabeled 12
Obstruction within device 12
Reaction 12
Tip breakage 12
Sticking 11
Component missing 11
Material frayed 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
Device packaging compromised 8
Delivery system failure 8
Device operates differently than expected 8
Collapse 6
Tracking 6
Total Device Problems 50653

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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