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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 628
Other (for use when an appropriate device code cannot be identified) 319
Premature deployment 175
Occlusion within device 102
Migration of device or device component 85
Deployment issue 81
Delivery system failure 63
Physical resistance 56
Break 50
Material separation 46
Fracture 41
Difficult to remove 40
Unknown (for use when the device problem is not known) 38
No code available 37
Failure to advance 33
Stretched 26
Inaccurate delivery 25
Difficult to deploy 23
Failure to deploy 21
Failure to expand 18
Kinked 17
Malposition of device 17
Unraveled material 14
Device remains implanted 14
Difficult to position 11
Difficult to advance 10
Not Applicable 9
Detachment of device component 9
Device operates differently than expected 8
Bent 7
Component(s), broken 6
Retraction problem 6
Device or device component damaged by another device 6
Positioning Issue 5
Device Issue 5
Device, or device fragments remain in patient 5
Interference 5
Difficult to insert 4
Collapse 4
Dislodged 4
Entrapment of device or device component 4
Improper or incorrect procedure or method 4
Unintended movement 4
Dislodged or dislocated 4
Device markings issue 3
No Information 3
Device, removal of (non-implant) 3
Material rupture 3
Blockage within device or device component 3
Lens, repositioning of 3
Nonstandard device or device component 2
Failure to flush 2
Delivery System Issue, No Description 2
Component missing 2
Unexpected therapeutic results 2
Tip breakage 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
Radiation Underexposure 1
Packaging issue 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
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
Total Device Problems 2158

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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