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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 42

Device Problems
Leak 5555
Occlusion within device 1358
Migration of device or device component 1110
No Known Device Problem 1016
Other (for use when an appropriate device code cannot be identified) 753
Inaccurate delivery 552
Kinked 511
Failure to Adhere or Bond 474
Difficult to remove 359
Difficult to position 297
Difficult to deploy 297
Implant, removal of 225
Break 201
Hole in material 190
Malposition of device 176
No Information 142
Deployment issue 105
Explanted 105
Dissection 95
Failure to deploy 86
Detachment of device component 85
Material separation 81
Material perforation 80
Use of Device Issue 74
Material rupture 50
Rupture due to trauma 49
Failure to unfold or unwrap 47
Unknown (for use when the device problem is not known) 47
Device operates differently than expected 43
Disconnection 37
Folded 32
Detachment of device or device component 28
Improper or incorrect procedure or method 27
Size incorrect for patient 27
Stretched 25
Difficult to advance 25
Unintended movement 25
Material deformation 25
Fracture 24
Component(s), broken 22
Not Applicable 22
User used incorrect product for intended use 21
Device expiration issue 19
Difficult to insert 18
Misplacement 18
No code available 18
Patient-device incompatibility 17
Failure to advance 17
Dislodged or dislocated 16
Positioning Issue 15
Inability to irrigate 14
Blockage within device or device component 14
Collapse 13
Fluid leak 13
Failure to separate 13
Physical resistance 13
Defective item 12
Retraction problem 12
Strut fracture 11
Tears, rips, holes in device, device material 11
Premature deployment 11
Material twisted 11
Device remains implanted 10
Device or device component damaged by another device 9
Twisting 8
Slippage of device or device component 7
Component or accessory incompatibility 7
Burst 7
Foreign material present in device 6
Device Issue 6
Sticking 6
Defective component 6
Torn material 6
Obstruction within device 5
Contamination during use 5
Material fragmentation 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
Bent 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
Failure to expand 4
Incompatibility problem 4
Pressure issue 4
Therapeutic or diagnostic output failure 3
Device-device incompatibility 3
Device, removal of (non-implant) 3
Delivery system failure 3
Dislodged 3
Flaked 3
Material invagination 3
Reaction 3
Total Device Problems 14972

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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