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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 791
Other (for use when an appropriate device code cannot be identified) 319
Premature deployment 192
Occlusion within device 102
Migration of device or device component 98
Deployment issue 93
Physical resistance 69
Delivery system failure 63
Break 60
Material separation 47
Difficult to remove 42
Fracture 41
Unknown (for use when the device problem is not known) 38
Failure to advance 38
No code available 38
Failure to expand 32
Difficult to deploy 31
Inaccurate delivery 26
Stretched 26
Failure to deploy 21
Kinked 18
Malposition of device 17
Unraveled material 14
Device remains implanted 14
Detachment of device component 13
Difficult to position 11
Device operates differently than expected 11
Difficult to advance 10
Retraction problem 10
Not Applicable 9
Bent 8
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
Improper or incorrect procedure or method 5
Device Issue 5
Difficult to insert 4
Collapse 4
Dislodged 4
Entrapment of device or device component 4
Unintended movement 4
Dislodged or dislocated 4
Device markings issue 3
Radiation Underexposure 3
No Information 3
Blockage within device or device component 3
Lens, repositioning of 3
Peeled 3
Device, removal of (non-implant) 3
Material rupture 3
Unexpected therapeutic results 2
Tip breakage 2
Delivery System Issue, No Description 2
Device damaged prior to use 2
Component missing 2
Leak 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
Foreign material present in device 1
Packaging issue 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
Device Difficult to Setup or Prepare 1
User used incorrect product for intended use 1
Material puncture 1
Failure to deliver 1
Aborted charge 1
Obstruction within device 1
Incomplete coaptation 1
Wire(s), breakage of 1
Wrinkled 1
Split 1
Defective item 1
Device or device fragments location unknown 1
Material perforation 1
Material rigid or stiff 1
Resistance, inadequate 1
Shaft break 1
Shipping damage or problem 1
Steering wire problem 1
Total Device Problems 2442

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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