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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device intracranial neurovascular stent
Definition An intracranial neurovascular stent is a tubular device placed in the blood vessel of the intracranial cavity to treat a vascular abnormality. It differs from other stents in that it is intended for intracranial use.
Product CodeNJE
Device Class Humanitarian Device Exemption

Device Problems
No Known Device Problem 545
Other (for use when an appropriate device code cannot be identified) 319
Premature deployment 165
Occlusion within device 98
Migration of device or device component 80
Deployment issue 78
Delivery system failure 63
Physical resistance 51
Break 47
Material separation 46
Fracture 41
Unknown (for use when the device problem is not known) 38
No code available 37
Difficult to remove 35
Stretched 26
Inaccurate delivery 25
Failure to advance 24
Difficult to deploy 21
Failure to deploy 21
Kinked 17
Malposition of device 16
Unraveled material 14
Device remains implanted 14
Failure to expand 13
Difficult to position 11
Difficult to advance 9
Not Applicable 8
Detachment of device component 7
Component(s), broken 6
Bent 6
Device operates differently than expected 6
Device or device component damaged by another device 6
Positioning Issue 5
Device, or device fragments remain in patient 5
Interference 5
Retraction problem 5
Improper or incorrect procedure or method 4
Difficult to insert 4
Collapse 4
Dislodged 4
Unintended movement 4
No Information 3
Dislodged or dislocated 3
Device markings issue 3
Entrapment of device or device component 3
Blockage within device or device component 3
Lens, repositioning of 3
Device, removal of (non-implant) 3
Material rupture 3
Device Issue 3
Delivery System Issue, No Description 2
Component missing 2
Unexpected therapeutic results 2
Tip breakage 2
Nonstandard device or device component 2
Failure to flush 2
Impedance issue 2
Difficult to open or close 2
Incorrect device or component shipped 1
Mechanical jam 1
Foreign material present in device 1
Packaging issue 1
Difficult to fold or unfold 1
Foreign material 1
Hole in material 1
Device expiration issue 1
Material discolored 1
Failure to capture 1
Component falling 1
Normal 1
Failure to pace or properly pace 1
Peeled 1
Leak 1
Device Difficult to Setup or Prepare 1
User used incorrect product for intended use 1
Material puncture 1
Shaft break 1
Steering wire problem 1
Material rigid or stiff 1
Resistance, inadequate 1
Failure to deliver 1
Material perforation 1
Device damaged prior to use 1
Wrinkled 1
Detachment of device or device component 1
Device disinfection or sterilization issue 1
Obstruction within device 1
Incomplete coaptation 1
Wire(s), breakage of 1
Split 1
Defective item 1
Device or device fragments location unknown 1
Total Device Problems 2010

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 1 2 1 0 1 1 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 Dec-16-2010
2 Boston Scientific Corporation II Nov-26-2010
3 Boston Scientific Corporation II Sep-09-2009
4 Codman & Shurtleff, Inc. II Jun-29-2011
5 Stryker Neurovascular II Dec-16-2014
6 Stryker Neurovascular II Jul-25-2013

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