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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 38

Device Problems
Leak 5316
Occlusion within device 1310
Migration of device or device component 1071
No Known Device Problem 960
Other (for use when an appropriate device code cannot be identified) 751
Inaccurate delivery 552
Kinked 501
Failure to Adhere or Bond 418
Difficult to remove 346
Difficult to position 294
Difficult to deploy 288
Implant, removal of 225
Break 192
Hole in material 159
Malposition of device 149
No Information 138
Explanted 105
Dissection 94
Deployment issue 88
Failure to deploy 82
Material perforation 80
Material separation 72
Detachment of device component 72
Use of Device Issue 67
Material rupture 50
Rupture due to trauma 49
Unknown (for use when the device problem is not known) 47
Failure to unfold or unwrap 46
Device operates differently than expected 37
Disconnection 37
Detachment of device or device component 27
Folded 27
Improper or incorrect procedure or method 26
Stretched 25
Size incorrect for patient 24
Component(s), broken 22
Not Applicable 22
Difficult to advance 20
Material deformation 18
Fracture 18
User used incorrect product for intended use 18
Misplacement 18
Difficult to insert 17
Device expiration issue 17
Patient-device incompatibility 16
Failure to advance 16
Positioning Issue 15
No code available 14
Dislodged or dislocated 14
Physical resistance 13
Failure to separate 12
Retraction problem 12
Fluid leak 12
Inability to irrigate 11
Premature deployment 11
Strut fracture 11
Tears, rips, holes in device, device material 11
Defective item 11
Unintended movement 11
Material twisted 11
Device remains implanted 10
Blockage within device or device component 9
Device or device component damaged by another device 9
Twisting 8
Slippage of device or device component 7
Burst 7
Sticking 6
Component or accessory incompatibility 6
Foreign material present in device 6
Device Issue 6
Obstruction within device 5
Defective component 5
Collapse 5
Contamination during use 5
Entrapment of device or device component 5
Occlusion, incorrect 5
Unintended collision 4
Device, or device fragments remain in patient 4
Device maintenance issue 4
Displacement 4
Material fragmentation 4
Bacterial contamination of device 4
Wire(s), breakage of 4
Device damaged prior to use 4
Seal, incorrect 4
Rupture, cause unknown 4
Tip breakage 4
Pressure issue 4
Failure to expand 4
Therapeutic or diagnostic output failure 3
Device, removal of (non-implant) 3
Device-device incompatibility 3
Flaked 3
Dislodged 3
Bent 3
Reaction 3
Product quality issue 2
Peeled 2
Mechanical issue 2
Material invagination 2
Total Device Problems 14281

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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