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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 53
Deployment issue 50
Occlusion within device 47
Break 40
Unknown (for use when the device problem is not known) 39
Migration of device or device component 30
No code available 29
Positioning Issue 23
No Information 19
Difficult to deploy 18
Difficult to remove 17
Premature deployment 17
No Known Device Problem 16
Material perforation 14
Normal 14
Device remains implanted 13
Difficult to position 13
Kinked 12
Fracture 11
Detachment of device component 11
Failure to expand 11
Handpiece break 10
Device damaged prior to use 8
Material deformation 7
Implant, removal of 6
Failure to advance 6
Explanted 6
Component(s), broken 6
Bent 6
Retraction problem 6
Dislodged 5
Obstruction within device 5
Detachment of device or device component 4
Blockage within device or device component 4
Unraveled material 4
Stretched 3
Difficult to insert 3
Difficult to advance 3
Torn material 2
Malposition of device 2
Physical resistance 2
Device Issue 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
Use of Device Issue 1
Suture line separation 1
Tears, rips, holes in device, device material 1
Tip breakage 1
Occlusion, incorrect 1
Mislabeled 1
Failure to separate 1
Device, removal of (non-implant) 1
Visibility/palpability 1
Implant, repositioning of 1
Failure to deliver 1
Inaccurate delivery 1
Not Applicable 1
Total Device Problems 685

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