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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 659
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 88
Deployment issue 82
Delivery system failure 63
Physical resistance 58
Break 52
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 24
Failure to expand 22
Failure to deploy 21
Kinked 17
Malposition of device 17
Unraveled material 14
Device remains implanted 14
Difficult to position 11
Detachment of device component 10
Difficult to advance 10
Not Applicable 9
Retraction problem 9
Device operates differently than expected 8
Bent 7
Component(s), broken 6
Device or device component damaged by another device 6
Positioning Issue 5
Device, or device fragments remain in patient 5
Interference 5
Device Issue 5
Improper or incorrect procedure or method 4
Difficult to insert 4
Collapse 4
Dislodged 4
Entrapment of device or device component 4
Dislodged or dislocated 4
Unintended movement 4
Device markings issue 3
No Information 3
Blockage within device or device component 3
Lens, repositioning of 3
Material rupture 3
Device, removal of (non-implant) 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
Difficult to open or close 2
Impedance issue 2
Incorrect device or component shipped 1
Item contaminated during manufacturing or shipping 1
Mechanical jam 1
Radiation Underexposure 1
Packaging issue 1
Foreign material present in device 1
Device-device incompatibility 1
Detachment of device or device component 1
Device disinfection or sterilization 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
Material perforation 1
Device damaged prior to use 1
Material rigid or stiff 1
Resistance, inadequate 1
Shaft break 1
Shipping damage or problem 1
Steering wire problem 1
Failure to deliver 1
Wire(s), breakage of 1
Obstruction within device 1
Incomplete coaptation 1
Split 1
Wrinkled 1
Defective item 1
Device or device fragments location unknown 1
Total Device Problems 2214

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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