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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 7

Device Problems
Leak 5919
Occlusion within device 1410
Migration of device or device component 1167
No Known Device Problem 1118
Other (for use when an appropriate device code cannot be identified) 753
Failure to Adhere or Bond 591
Inaccurate delivery 552
Kinked 520
Difficult to remove 374
Difficult to position 307
Difficult to deploy 306
Hole in material 248
Implant, removal of 225
Malposition of device 214
Break 211
No Information 146
Deployment issue 127
Detachment of device component 106
Explanted 105
Failure to deploy 96
Dissection 95
Material separation 86
Material perforation 80
Use of Device Issue 79
Material rupture 54
Unintended movement 50
Rupture due to trauma 49
Unknown (for use when the device problem is not known) 47
Failure to unfold or unwrap 47
Device operates differently than expected 47
Disconnection 37
Folded 35
Fracture 34
Difficult to advance 33
Improper or incorrect procedure or method 31
Material deformation 30
Detachment of device or device component 29
Stretched 28
Size incorrect for patient 27
User used incorrect product for intended use 27
No code available 27
Not Applicable 22
Component(s), broken 22
Device expiration issue 21
Collapse 21
Difficult to insert 19
Positioning Issue 19
Misplacement 18
Blockage within device or device component 18
Fluid leak 18
Inability to irrigate 18
Failure to advance 18
Dislodged or dislocated 17
Patient-device incompatibility 17
Failure to separate 14
Retraction problem 14
Physical resistance 13
Device or device component damaged by another device 13
Material twisted 12
Defective item 12
Strut fracture 11
Tears, rips, holes in device, device material 11
Premature deployment 11
Device remains implanted 10
Burst 9
Torn material 9
Twisting 8
Component or accessory incompatibility 8
Slippage of device or device component 7
Sticking 6
Defective component 6
Device Issue 6
Bent 6
Material fragmentation 6
Entrapment of device or device component 6
Failure to expand 6
Foreign material present in device 6
Packaging issue 5
Contamination during use 5
Occlusion, incorrect 5
Material invagination 5
Obstruction within device 5
Wire(s), breakage of 4
Device markings issue 4
Device damaged prior to use 4
Bacterial contamination of device 4
Tip breakage 4
Seal, incorrect 4
Rupture, cause unknown 4
Device maintenance issue 4
Unintended collision 4
Device, or device fragments remain in patient 4
Displacement 4
Pressure issue 4
Incompatibility problem 4
Device-device incompatibility 3
Therapeutic or diagnostic output failure 3
Dislodged 3
Reaction 3
Flaked 3
Total Device Problems 16017

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 7
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 Oct-25-2013
12 Medtronic Vascular, Inc. II Mar-23-2012
13 Trivascular, Inc I Nov-03-2014
14 Trivascular, Inc II Mar-26-2014
15 Trivascular, Inc II Nov-13-2012

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