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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, tracheal, expandable
Regulation Description Tracheal prosthesis.
Product CodeJCT
Regulation Number 878.3720
Device Class 2


Premarket Reviews
ManufacturerDecision
ALVEOLUS, INC
  SE - WITH LIMITATIONS 3
ATRIUM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  6
  SUBSTANTIALLY EQUIVALENT 9
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SULZER
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR ARCHITECTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Failure to deploy 171
Deployment issue 109
Fracture 101
No code available 90
Other (for use when an appropriate device code cannot be identified) 50
Difficult to deploy 43
Positioning Issue 42
Break 40
Detachment of device component 34
Difficult to remove 30
Suture line separation 24
Migration of device or device component 23
Kinked 19
Component(s), broken 15
Failure to expand 15
Occlusion within device 14
Leak 11
No Known Device Problem 11
Dislodged or dislocated 10
Premature deployment 9
Knotted 8
Failure to advance 7
Malposition of device 7
Device damaged prior to use 6
Difficult to position 6
Bent 6
Physical resistance 6
Detachment of device or device component 6
Material deformation 5
Fitting problem 5
Implant, removal of 5
Device Issue 5
Material perforation 4
Device remains implanted 4
Size incorrect for patient 4
Misplacement 3
Sticking 3
Suture line disruption 3
Collapse 3
Explanted 3
Inflation issue 3
Looping 3
Loose or intermittent connection 3
Misassembled 2
Dislodged 2
Blockage within device or device component 2
Unknown (for use when the device problem is not known) 2
Failure to separate 2
Retraction problem 2
Material separation 2
Slippage of device or device component 2
Tears, rips, holes in device, device material 2
Tip breakage 2
Unraveled material 2
Material integrity issue 2
Difficult to advance 2
Incorrect device or component shipped 1
Device markings issue 1
Device packaging compromised 1
Material twisted 1
Torn material 1
No Information 1
Failure to unfold or unwrap 1
Source, detachment from 1
Sterility 1
Shaft break 1
Shelf life exceeded 1
Material rupture 1
Implant breakage or physical damage 1
Buckled material 1
Tear, rip or hole in device packaging 1
Cut in material 1
Failure to deliver 1
Wire(s), breakage of 1
Defective component 1
Component missing 1
Burst 1
Component falling 1
Crack 1
Deflation issue 1
Entrapment of device or device component 1
Device expiration issue 1
Flaked 1
Difficult to flush 1
Peeled 1
Mechanical issue 1
Handpiece break 1
Handpiece detachment 1
Hole in material 1
Total Device Problems 1028

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

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Apr-25-2016
2 Boston Scientific Corporation II Jul-15-2011
3 Boston Scientific Corporation II Aug-31-2010
4 Boston Scientific Corporation II Jun-25-2010
5 EXP Pharmaceutical Services Corp II Jul-24-2015

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