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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 537
Other (for use when an appropriate device code cannot be identified) 319
Premature deployment 163
Occlusion within device 97
Deployment issue 77
Migration of device or device component 77
Delivery system failure 63
Physical resistance 50
Material separation 45
Break 44
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 23
Difficult to deploy 21
Failure to deploy 20
Kinked 16
Malposition of device 16
Device remains implanted 14
Unraveled material 14
Failure to expand 11
Difficult to position 11
Difficult to advance 8
Detachment of device component 7
Not Applicable 7
Device operates differently than expected 6
Device or device component damaged by another device 6
Component(s), broken 6
Positioning Issue 5
Interference 5
Bent 5
Device, or device fragments remain in patient 5
Retraction problem 5
Improper or incorrect procedure or method 4
Difficult to insert 4
Collapse 4
Dislodged 4
Unintended movement 4
Blockage within device or device component 3
Device, removal of (non-implant) 3
Lens, repositioning of 3
No Information 3
Device markings issue 3
Material rupture 3
Entrapment of device or device component 3
Dislodged or dislocated 3
Difficult to open or close 2
Component missing 2
Unexpected therapeutic results 2
Tip breakage 2
Delivery System Issue, No Description 2
Impedance issue 2
Failure to flush 2
Nonstandard device or device component 2
Device expiration issue 1
Split 1
Defective item 1
Device or device fragments location unknown 1
Detachment of device or device component 1
Packaging issue 1
Material perforation 1
Component falling 1
Failure to pace or properly pace 1
Device damaged prior to use 1
Incomplete coaptation 1
Device disinfection or sterilization issue 1
Foreign material present in device 1
Incorrect device or component shipped 1
Normal 1
Peeled 1
Resistance, inadequate 1
Shaft break 1
Difficult to fold or unfold 1
Leak 1
Mechanical jam 1
Material rigid or stiff 1
Hole in material 1
User used incorrect product for intended use 1
Steering wire problem 1
Wire(s), breakage of 1
Device Issue 1
Wrinkled 1
Foreign material 1
Failure to capture 1
Material discolored 1
Failure to deliver 1
Obstruction within device 1
Device Difficult to Setup or Prepare 1
Material puncture 1
Total Device Problems 1980

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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