• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 62

Device Problems
Occlusion within device 7362
Failure to advance 5082
No Known Device Problem 4856
Device remains implanted 4524
Bent 3440
Device damaged prior to use 2845
Unknown (for use when the device problem is not known) 2750
Dislodged or dislocated 1887
Dislodged 1448
Difficult to remove 1258
Not Applicable 1072
Material deformation 653
Fracture 621
Other (for use when an appropriate device code cannot be identified) 599
Use of Device Issue 563
Break 484
Shaft break 471
Crack 443
Kinked 410
Device or device component damaged by another device 323
Inflation issue 304
Deployment issue 303
Dissection 300
Failure to deliver 274
Improper or incorrect procedure or method 270
Leak 239
Detachment of device component 238
Balloon rupture 197
Migration of device or device component 189
Difficult to deploy 186
Device, or device fragments remain in patient 181
Burst 165
Deflation issue 164
Loose 158
Material rupture 138
Balloon burst 137
Difficult to insert 134
Underdelivery 133
Difficult to position 128
Malposition of device 116
Physical resistance 93
Material separation 90
Entrapment of device or device component 87
Source, detachment from 86
Failure to deploy 83
Inaccurate delivery 70
Balloon leak(s) 68
Slippage of device or device component 66
Difficult to advance 66
Device expiration issue 59
Strut fracture 54
No Information 50
Device or device fragments location unknown 47
Stretched 43
Blockage within device or device component 37
Unintended movement 34
Misapplication 32
Detachment of device or device component 31
Foreign material 29
Out-of-box failure 29
Foreign material present in device 28
Size incorrect for patient 26
Explanted 23
Material Distortion 22
Premature deployment 21
No code available 20
Interference 18
Unstable 18
Hole in material 18
Device, removal of (non-implant) 17
Misplacement 16
Material perforation 16
Positioning Issue 15
Balloon pinhole 14
Defective item 13
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 component 9
Implant, removal of 9
Component missing 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 46732

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

-
-