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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 36

Device Problems
Leak 5204
Occlusion within device 1284
Migration of device or device component 1052
No Known Device Problem 938
Other (for use when an appropriate device code cannot be identified) 751
Inaccurate delivery 552
Kinked 496
Failure to Adhere or Bond 395
Difficult to remove 344
Difficult to position 291
Difficult to deploy 286
Implant, removal of 225
Break 190
Hole in material 145
Malposition of device 138
No Information 136
Explanted 105
Dissection 94
Deployment issue 83
Material perforation 80
Failure to deploy 80
Detachment of device component 71
Material separation 69
Use of Device Issue 64
Material rupture 50
Rupture due to trauma 49
Unknown (for use when the device problem is not known) 47
Failure to unfold or unwrap 45
Disconnection 37
Device operates differently than expected 35
Detachment of device or device component 27
Folded 25
Stretched 25
Improper or incorrect procedure or method 25
Size incorrect for patient 23
Component(s), broken 22
Not Applicable 21
Difficult to advance 20
Misplacement 18
Material deformation 18
Difficult to insert 17
Device expiration issue 17
Fracture 16
User used incorrect product for intended use 16
Failure to advance 16
Positioning Issue 15
No code available 14
Patient-device incompatibility 14
Dislodged or dislocated 14
Physical resistance 13
Retraction problem 12
Fluid leak 12
Inability to irrigate 11
Strut fracture 11
Tears, rips, holes in device, device material 11
Defective item 11
Material twisted 11
Failure to separate 10
Premature deployment 10
Device remains implanted 10
Unintended movement 9
Blockage within device or device component 8
Twisting 8
Slippage of device or device component 7
Device or device component damaged by another device 7
Foreign material present in device 6
Device Issue 6
Component or accessory incompatibility 6
Sticking 6
Burst 6
Collapse 5
Entrapment of device or device component 5
Occlusion, incorrect 5
Defective component 5
Obstruction within device 5
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
Unintended collision 4
Device, or device fragments remain in patient 4
Device maintenance issue 4
Displacement 4
Contamination during use 4
Pressure issue 4
Failure to expand 4
Therapeutic or diagnostic output failure 3
Device, removal of (non-implant) 3
Bent 3
Dislodged 3
Material fragmentation 3
Reaction 3
Device-device incompatibility 3
Device markings issue 2
Human-Device Interface Issue 2
Incompatibility problem 2
Mechanical jam 2
Failure to align 2
Total Device Problems 13998

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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