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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, neurovascular embolization
Regulation Description Neurovascular embolization device.
Product CodeHCG
Regulation Number 882.5950
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOCOMPATIBLES, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOCURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSPHERE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 20
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 6
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 13
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 11
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 31
MICRUS
  SUBSTANTIALLY EQUIVALENT 16
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 6
RJ Medical, Inc.
  SUBSTANTIALLY EQUIVALENT 1
SCION CARDIO-VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGICA CORP.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Known Device Problem 986
Physical resistance 850
Failure to advance 787
Stretched 713
Detachment of device component 639
Other (for use when an appropriate device code cannot be identified) 570
Premature deployment 554
Break 376
Failure to deploy 371
Unraveled material 271
Kinked 262
Migration of device or device component 197
Mechanical jam 183
Difficult to advance 165
Device handling issue 150
Device operates differently than expected 125
Failure to separate 121
Device Issue 117
No code available 108
Bent 105
Difficult to position 84
Retraction problem 79
Fracture 70
Unknown (for use when the device problem is not known) 70
Out-of-box failure 66
Material separation 65
Device damaged prior to use 58
Deployment issue 57
Delivery system failure 51
Difficult to remove 47
Mechanical issue 46
Detachment of device or device component 46
Entrapment of device or device component 41
Buckled material 39
Material Protrusion 39
Malposition of device 37
Material deformation 36
Difficult to deploy 34
Occlusion within device 29
Positioning Issue 29
Device Difficult to Setup or Prepare 24
Size incorrect for patient 22
Air leak 22
Leak 22
Difficult or delayed activation 22
Crack 21
Device, or device fragments remain in patient 21
No Information 19
Device or device component damaged by another device 17
Use of Device Issue 15
Material rupture 15
Device-device incompatibility 14
Device, removal of (non-implant) 13
Unintended movement 12
Device remains implanted 11
Component(s), broken 9
Lens, repositioning of 9
Not Applicable 9
Device markings issue 9
Defective item 9
Structural problem 8
Patient-device incompatibility 8
Difficult to insert 8
Failure to fold 8
Knotted 8
Therapeutic or diagnostic output failure 7
Dislodged or dislocated 7
Material integrity issue 7
Foreign material present in device 6
Unable to confirm conditions of use 5
Failure to disconnect 5
Inaccurate delivery 5
Difficult to fold or unfold 5
Material disintegration 5
Blockage within device or device component 5
Component falling 4
Unsealed device packaging 4
Sticking 4
Component missing 4
Device or device fragments location unknown 4
Connection issue 4
Torn material 4
Packaging issue 3
Delivery System Issue, No Description 3
Improper or incorrect procedure or method 3
Material rigid or stiff 3
Slippage of device or device component 3
Peeled 3
Contamination during use 3
Failure to flush 3
Interference 2
Material frayed 2
Looping 2
Dislodged 2
Electrical issue 2
Failure to discharge 2
Disconnection 2
Coagulation in device or device ingredient 2
Coiled 2
Failure to prime 2
Total Device Problems 9157

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 1 0 0 0 0 0 0
Class II 1 0 0 0 1 0 1 1 0 2 0
Class III 0 1 0 0 0 2 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Target II Mar-29-2007
2 Cook, Inc. III Sep-16-2008
3 Micro Therapeutics Inc, dba ev3 Neurovascular III Jan-26-2012
4 Micro Therapeutics Inc, dba ev3 Neurovascular III Jan-24-2012
5 Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131 II Jan-03-2011
6 Penumbra Inc. I Apr-12-2011
7 Stryker Neurovascular II Jul-11-2016
8 Stryker Neurovascular II Apr-19-2016
9 Stryker Neurovascular II Dec-16-2014
10 Stryker Neurovascular II Dec-13-2013

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