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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 2017
34 48 54 53 68 62 53 81 53 48 0

Device Problems
Leak 5805
Occlusion within device 1395
Migration of device or device component 1145
No Known Device Problem 1091
Other (for use when an appropriate device code cannot be identified) 753
Inaccurate delivery 552
Failure to Adhere or Bond 547
Kinked 519
Difficult to remove 368
Difficult to position 304
Difficult to deploy 302
Implant, removal of 225
Hole in material 223
Break 209
Malposition of device 197
No Information 144
Deployment issue 119
Explanted 105
Dissection 95
Failure to deploy 95
Detachment of device component 95
Material separation 85
Material perforation 80
Use of Device Issue 78
Material rupture 53
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 46
Disconnection 37
Unintended movement 35
Folded 34
Difficult to advance 31
Fracture 30
Detachment of device or device component 29
Improper or incorrect procedure or method 29
Size incorrect for patient 27
Material deformation 27
Stretched 26
User used incorrect product for intended use 25
No code available 25
Not Applicable 22
Component(s), broken 22
Device expiration issue 21
Difficult to insert 19
Misplacement 18
Collapse 18
Positioning Issue 18
Fluid leak 17
Dislodged or dislocated 17
Patient-device incompatibility 17
Failure to advance 17
Inability to irrigate 15
Blockage within device or device component 15
Failure to separate 14
Physical resistance 13
Retraction problem 13
Defective item 12
Device or device component damaged by another device 12
Material twisted 12
Strut fracture 11
Tears, rips, holes in device, device material 11
Premature deployment 11
Device remains implanted 10
Twisting 8
Component or accessory incompatibility 8
Torn material 8
Slippage of device or device component 7
Burst 7
Bent 6
Material fragmentation 6
Entrapment of device or device component 6
Sticking 6
Defective component 6
Device Issue 6
Failure to expand 6
Foreign material present in device 6
Packaging issue 5
Obstruction within device 5
Contamination during use 5
Occlusion, incorrect 5
Unintended collision 4
Device, or device fragments remain in patient 4
Material invagination 4
Device maintenance issue 4
Displacement 4
Wire(s), breakage of 4
Device damaged prior to use 4
Bacterial contamination of device 4
Tip breakage 4
Seal, incorrect 4
Rupture, cause unknown 4
Pressure issue 4
Incompatibility problem 4
Delivery system failure 3
Therapeutic or diagnostic output failure 3
Failure to align 3
Device, removal of (non-implant) 3
Device-device incompatibility 3
Dislodged 3
Total Device Problems 15659

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 1 0 0 0
Class II 0 1 0 0 0 2 1 1 1 0 0
Class III 0 0 0 0 1 0 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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