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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 3 (513(f)(1))

Device Problems
No Known Device Problem 409
Other (for use when an appropriate device code cannot be identified) 319
Premature deployment 137
Occlusion within device 90
Migration of device or device component 69
Deployment issue 63
Delivery system failure 62
Material separation 45
Fracture 40
Break 39
Unknown (for use when the device problem is not known) 38
No code available 37
Physical resistance 36
Difficult to remove 28
Stretched 25
Inaccurate delivery 25
Difficult to deploy 18
Failure to deploy 17
Failure to advance 16
Kinked 15
Device remains implanted 14
Unraveled material 14
Malposition of device 14
Difficult to position 10
Component(s), broken 6
Detachment of device component 6
Device or device component damaged by another device 6
Interference 5
Retraction problem 5
Device, or device fragments remain in patient 5
Bent 4
Difficult to insert 4
Collapse 4
Dislodged 4
Difficult to advance 4
Device operates differently than expected 4
Improper or incorrect procedure or method 4
Device operational issue 3
Dislodged or dislocated 3
Device, removal of (non-implant) 3
Entrapment of device or device component 3
Lens, repositioning of 3
Material rupture 3
Unintended movement 3
No Information 2
Positioning Issue 2
Impedance issue 2
Nonstandard device or device component 2
Difficult to open or close 2
Delivery System Issue, No Description 2
Unexpected therapeutic results 2
Tip breakage 2
Component missing 2
Failure to deliver 1
Split 1
Wire(s), breakage of 1
Device Issue 1
Obstruction within device 1
Incomplete coaptation 1
Material perforation 1
Device damaged prior to use 1
Foreign material present in device 1
Human factors issue 1
Wrinkled 1
Defective item 1
Device or device fragments location unknown 1
Detachment of device or device component 1
Device disinfection or sterilization issue 1
Device markings issue 1
Normal 1
Failure to pace or properly pace 1
Material puncture 1
Shaft break 1
Steering wire problem 1
Material rigid or stiff 1
Resistance, inadequate 1
Leak 1
Hole in material 1
Failure to flush 1
Difficult to fold or unfold 1
Foreign material 1
Component falling 1
Incorrect device or component shipped 1
Mechanical jam 1
Packaging issue 1
Total Device Problems 1712

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

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