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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 5685
Occlusion within device 1376
Migration of device or device component 1130
No Known Device Problem 1055
Other (for use when an appropriate device code cannot be identified) 753
Inaccurate delivery 552
Kinked 515
Failure to Adhere or Bond 508
Difficult to remove 362
Difficult to position 303
Difficult to deploy 297
Implant, removal of 225
Break 204
Hole in material 202
Malposition of device 188
No Information 144
Deployment issue 114
Explanted 105
Dissection 95
Failure to deploy 91
Detachment of device component 88
Material separation 83
Material perforation 80
Use of Device Issue 76
Material rupture 51
Rupture due to trauma 49
Unknown (for use when the device problem is not known) 47
Failure to unfold or unwrap 47
Device operates differently than expected 44
Disconnection 37
Folded 33
Detachment of device or device component 28
Improper or incorrect procedure or method 28
Size incorrect for patient 27
Difficult to advance 27
Stretched 26
Fracture 26
Unintended movement 26
Material deformation 26
User used incorrect product for intended use 24
Component(s), broken 22
Not Applicable 22
Device expiration issue 20
Difficult to insert 19
Misplacement 18
No code available 18
Dislodged or dislocated 17
Patient-device incompatibility 17
Failure to advance 17
Positioning Issue 16
Inability to irrigate 15
Failure to separate 14
Fluid leak 14
Collapse 14
Blockage within device or device component 14
Physical resistance 13
Defective item 12
Retraction problem 12
Strut fracture 11
Tears, rips, holes in device, device material 11
Device or device component damaged by another device 11
Premature deployment 11
Material twisted 11
Device remains implanted 10
Component or accessory incompatibility 8
Twisting 8
Slippage of device or device component 7
Burst 7
Material fragmentation 6
Sticking 6
Defective component 6
Foreign material present in device 6
Device Issue 6
Torn material 6
Packaging issue 5
Obstruction within device 5
Entrapment of device or device component 5
Bent 5
Contamination during use 5
Occlusion, incorrect 5
Unintended collision 4
Device, or device fragments remain in patient 4
Device maintenance issue 4
Material invagination 4
Displacement 4
Bacterial contamination of device 4
Wire(s), breakage of 4
Device damaged prior to use 4
Rupture, cause unknown 4
Seal, incorrect 4
Tip breakage 4
Pressure issue 4
Incompatibility problem 4
Failure to expand 4
Therapeutic or diagnostic output failure 3
Delivery system failure 3
Device-device incompatibility 3
Failure to align 3
Device, removal of (non-implant) 3
Dislodged 3
Total Device Problems 15306

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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