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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device system, endovascular graft, aortic aneurysm treatment
Product CodeMIH
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
34 48 54 53 68 62 53 81 53 48 11

Device Problems
Leak 6278
Occlusion within device 1478
Migration of device or device component 1226
No Known Device Problem 1204
Other (for use when an appropriate device code cannot be identified) 753
Failure to Adhere or Bond 642
Inaccurate delivery 552
Kinked 529
Difficult to remove 382
Difficult to deploy 322
Difficult to position 321
Hole in material 298
Malposition of device 254
Break 228
Implant, removal of 225
No Information 153
Deployment issue 145
Detachment of device component 122
Explanted 105
Failure to deploy 101
Dissection 95
Failure to advance 93
Material separation 92
Use of Device Issue 84
Material perforation 80
Unintended movement 68
Material rupture 54
No code available 51
Failure to unfold or unwrap 50
Rupture due to trauma 49
Device operates differently than expected 48
Unknown (for use when the device problem is not known) 47
Fracture 43
Folded 39
Improper or incorrect procedure or method 37
Disconnection 37
Difficult to advance 34
Material deformation 32
Difficult to insert 32
User used incorrect product for intended use 32
Detachment of device or device component 32
Stretched 30
Size incorrect for patient 29
Torn material 26
Blockage within device or device component 24
Collapse 23
Component(s), broken 22
Not Applicable 22
Dislodged or dislocated 21
Device expiration issue 21
Fluid leak 19
Device or device component damaged by another device 19
Patient-device incompatibility 19
Positioning Issue 19
Misplacement 18
Inability to irrigate 18
Failure to separate 15
Retraction problem 15
Defective item 14
Physical resistance 13
Material twisted 13
Material frayed 12
Premature deployment 12
Strut fracture 11
Tears, rips, holes in device, device material 11
Device remains implanted 10
Burst 9
Twisting 8
Component or accessory incompatibility 8
Slippage of device or device component 7
Bent 7
Material fragmentation 6
Entrapment of device or device component 6
Material invagination 6
Sticking 6
Device damaged prior to use 6
Defective component 6
Device Issue 6
Packaging issue 6
Foreign material present in device 6
Failure to expand 6
Obstruction within device 5
Occlusion, incorrect 5
Contamination during use 5
Displacement 4
Unintended collision 4
Device maintenance issue 4
Wire(s), breakage of 4
Device-device incompatibility 4
Device markings issue 4
Bacterial contamination of device 4
Tip breakage 4
Device, or device fragments remain in patient 4
Seal, incorrect 4
Rupture, cause unknown 4
Pressure issue 4
Incompatibility problem 4
Therapeutic or diagnostic output failure 3
Material integrity issue 3
Device, removal of (non-implant) 3
Total Device Problems 17078

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 1 0 0 0
Class II 0 1 0 0 0 2 1 1 1 0 8
Class III 0 0 0 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Nov-05-2015
2 Cook, Inc. III Sep-06-2011
3 Endologix II Jan-19-2017
4 Endologix II Jan-19-2017
5 Endologix II Jan-19-2017
6 Endologix II Jan-19-2017
7 Endologix II Jan-18-2017
8 Endologix II Jan-18-2017
9 Endologix II Jan-18-2017
10 Medtronic CardioVascular II Apr-08-2008
11 Medtronic Vascular, Inc. II Mar-15-2017
12 Medtronic Vascular, Inc. II Oct-25-2013
13 Medtronic Vascular, Inc. II Mar-23-2012
14 Trivascular, Inc I Nov-03-2014
15 Trivascular, Inc II Mar-26-2014
16 Trivascular, Inc II Nov-13-2012

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