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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
34 48 54 53 68 62 53 81 53 25

Device Problems
Leak 4910
Occlusion within device 1249
Migration of device or device component 1001
No Known Device Problem 883
Other (for use when an appropriate device code cannot be identified) 751
Inaccurate delivery 552
Kinked 492
Difficult to remove 339
Failure to Adhere or Bond 308
Difficult to deploy 283
Difficult to position 283
Implant, removal of 225
Break 177
No Information 129
Hole in material 111
Explanted 105
Malposition of device 99
Dissection 94
Material perforation 80
Failure to deploy 79
Deployment issue 73
Material separation 68
Use of Device Issue 61
Material rupture 50
Rupture due to trauma 49
Unknown (for use when the device problem is not known) 47
Failure to unfold or unwrap 42
Detachment of device component 38
Disconnection 37
Device operates differently than expected 35
Detachment of device or device component 27
Stretched 24
Improper or incorrect procedure or method 23
Folded 22
Component(s), broken 22
Not Applicable 21
Difficult to advance 19
Size incorrect for patient 18
Misplacement 18
Device expiration issue 17
Difficult to insert 16
Failure to advance 16
Positioning Issue 15
Patient-device incompatibility 13
Physical resistance 13
Fracture 13
No code available 13
Retraction problem 12
Material deformation 12
Defective item 11
Strut fracture 11
Tears, rips, holes in device, device material 11
User used incorrect product for intended use 11
Fluid leak 11
Premature deployment 10
Device remains implanted 10
Failure to separate 9
Dislodged or dislocated 9
Material twisted 9
Twisting 8
Slippage of device or device component 7
Inability to irrigate 7
Blockage within device or device component 7
Sticking 6
Device Issue 6
Component or accessory incompatibility 6
Device or device component damaged by another device 5
Foreign material present in device 5
Obstruction within device 5
Burst 5
Entrapment of device or device component 5
Occlusion, incorrect 5
Unintended movement 5
Device maintenance issue 4
Rupture, cause unknown 4
Device, or device fragments remain in patient 4
Unintended collision 4
Displacement 4
Collapse 4
Wire(s), breakage of 4
Defective component 4
Bacterial contamination of device 4
Tip breakage 4
Seal, incorrect 4
Pressure issue 4
Therapeutic or diagnostic output failure 3
Device, removal of (non-implant) 3
Device damaged prior to use 3
Bent 3
Contamination during use 3
Dislodged 3
Reaction 3
Product quality issue 2
Material invagination 2
Dislocated 2
Flaked 2
Foreign material 2
Material fragmentation 2
Air eliminator, defective 2
Failure to align 2
Total Device Problems 13253

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 1 0 0
Class II 0 1 0 0 0 2 1 1 1 0
Class III 0 0 0 0 1 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 Medtronic CardioVascular II Apr-08-2008
4 Medtronic Vascular, Inc. II Oct-25-2013
5 Medtronic Vascular, Inc. II Mar-23-2012
6 Trivascular, Inc I Nov-03-2014
7 Trivascular, Inc II Mar-26-2014
8 Trivascular, Inc II Nov-13-2012

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