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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 9

Device Problems
Leak 4738
Occlusion within device 1220
Migration of device or device component 967
No Known Device Problem 836
Other (for use when an appropriate device code cannot be identified) 751
Inaccurate delivery 552
Kinked 485
Difficult to remove 332
Difficult to deploy 283
Difficult to position 279
Failure to Adhere or Bond 244
Implant, removal of 225
Break 174
No Information 126
Explanted 105
Hole in material 100
Dissection 94
Material perforation 80
Malposition of device 80
Failure to deploy 79
Deployment issue 68
Material separation 67
Use of Device Issue 60
Rupture due to trauma 49
Material rupture 49
Unknown (for use when the device problem is not known) 47
Failure to unfold or unwrap 42
Disconnection 37
Device operates differently than expected 33
Detachment of device component 30
Detachment of device or device component 27
Stretched 24
Folded 22
Component(s), broken 22
Not Applicable 21
Improper or incorrect procedure or method 20
Difficult to advance 19
Misplacement 18
Device expiration issue 17
Size incorrect for patient 17
Failure to advance 16
Positioning Issue 15
Difficult to insert 15
Patient-device incompatibility 13
Physical resistance 13
Material deformation 12
Fracture 12
Retraction problem 12
User used incorrect product for intended use 11
Defective item 11
Strut fracture 11
Tears, rips, holes in device, device material 11
No code available 11
Premature deployment 10
Device remains implanted 10
Fluid leak 9
Material twisted 9
Twisting 8
Failure to separate 8
Dislodged or dislocated 8
Slippage of device or device component 7
Blockage within device or device component 7
Inability to irrigate 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
Occlusion, incorrect 5
Burst 5
Entrapment of device or device component 5
Displacement 4
Device maintenance issue 4
Rupture, cause unknown 4
Device, or device fragments remain in patient 4
Unintended collision 4
Pressure issue 4
Obstruction within device 4
Wire(s), breakage of 4
Defective component 4
Tip breakage 4
Seal, incorrect 4
Bacterial contamination of device 3
Device damaged prior to use 3
Therapeutic or diagnostic output failure 3
Device, removal of (non-implant) 3
Reaction 3
Dislodged 3
Bent 3
Contamination during use 3
Unintended movement 3
Mechanical jam 2
Failure to expand 2
Collapse 2
Dislocated 2
Flaked 2
Foreign material 2
Product quality issue 2
Material invagination 2
Device markings issue 2
Total Device Problems 12817

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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