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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stent, colonic, metalic, expandable
Regulation Description Esophageal prosthesis.
Product CodeMQR
Regulation Number 878.3610
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 7
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
MED INSTITUTE, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 65
Failure to deploy 52
Occlusion within device 47
Unknown (for use when the device problem is not known) 39
Break 38
Deployment issue 36
No code available 29
Migration of device or device component 28
Difficult to deploy 18
Positioning Issue 16
Difficult to remove 15
Normal 14
Material perforation 14
Difficult to position 13
Device remains implanted 13
Kinked 12
No Known Device Problem 12
No Information 11
Premature deployment 11
Fracture 11
Detachment of device component 11
Handpiece break 10
Failure to expand 10
Device damaged prior to use 8
Implant, removal of 6
Failure to advance 6
Material deformation 6
Explanted 6
Component(s), broken 6
Bent 6
Retraction problem 6
Dislodged 5
Obstruction within device 5
Unraveled material 4
Blockage within device or device component 4
Stretched 3
Difficult to insert 3
Detachment of device or device component 3
Difficult to advance 3
Malposition of device 2
Torn material 2
Device Issue 2
Physical resistance 2
Misplacement 2
Device, or device fragments remain in patient 2
Collapse 2
Dislocated 1
Material erosion 1
Hole in material 1
Material frayed 1
Suture line separation 1
Tears, rips, holes in device, device material 1
Tip breakage 1
Occlusion, incorrect 1
Mislabeled 1
Device, removal of (non-implant) 1
Visibility/palpability 1
Failure to separate 1
Use of Device Issue 1
Implant, repositioning of 1
Failure to deliver 1
Inaccurate delivery 1
Not Applicable 1
Total Device Problems 636

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 1 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Aug-31-2010

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