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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 647
Other (for use when an appropriate device code cannot be identified) 319
Premature deployment 177
Occlusion within device 102
Migration of device or device component 87
Deployment issue 82
Delivery system failure 63
Physical resistance 58
Break 51
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 36
Stretched 26
Inaccurate delivery 25
Difficult to deploy 23
Failure to expand 21
Failure to deploy 21
Malposition of device 17
Kinked 17
Device remains implanted 14
Unraveled material 14
Difficult to position 11
Difficult to advance 10
Detachment of device component 9
Not Applicable 9
Device operates differently than expected 8
Bent 7
Retraction problem 7
Device or device component damaged by another device 6
Component(s), broken 6
Positioning Issue 5
Device Issue 5
Interference 5
Device, or device fragments remain in patient 5
Improper or incorrect procedure or method 4
Dislodged or dislocated 4
Unintended movement 4
Dislodged 4
Entrapment of device or device component 4
Difficult to insert 4
Collapse 4
No Information 3
Material rupture 3
Device markings issue 3
Lens, repositioning of 3
Device, removal of (non-implant) 3
Blockage within device or device component 3
Impedance issue 2
Failure to flush 2
Nonstandard device or device component 2
Component missing 2
Difficult to open or close 2
Unexpected therapeutic results 2
Tip breakage 2
Delivery System Issue, No Description 2
Wrinkled 1
Foreign material 1
Failure to capture 1
Material discolored 1
Device Difficult to Setup or Prepare 1
Obstruction within device 1
Material puncture 1
Shipping damage or problem 1
Failure to deliver 1
Packaging issue 1
Detachment of device or device component 1
Device expiration issue 1
Device or device fragments location unknown 1
Defective item 1
Split 1
Material perforation 1
Device damaged prior to use 1
Incomplete coaptation 1
Component falling 1
Failure to pace or properly pace 1
Radiation Underexposure 1
Device disinfection or sterilization issue 1
Item contaminated during manufacturing or shipping 1
Resistance, inadequate 1
Normal 1
Difficult to fold or unfold 1
Leak 1
Foreign material present in device 1
Shaft break 1
Incorrect device or component shipped 1
Peeled 1
Mechanical jam 1
Material rigid or stiff 1
Wire(s), breakage of 1
User used incorrect product for intended use 1
Steering wire problem 1
Hole in material 1
Total Device Problems 2194

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 1 2 1 0 1 1 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 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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