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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 948
Stretched 640
Failure to advance 582
Physical resistance 570
Other (for use when an appropriate device code cannot be identified) 570
Premature deployment 502
Detachment of device component 469
Failure to deploy 339
Break 328
Unraveled material 257
Kinked 196
Migration of device or device component 174
Difficult to advance 149
Mechanical jam 121
Device Issue 117
No code available 103
Device handling issue 83
Bent 80
Failure to separate 79
Device operates differently than expected 73
Unknown (for use when the device problem is not known) 70
Fracture 65
Difficult to position 62
Retraction problem 59
Deployment issue 57
Material separation 57
Out-of-box failure 51
Delivery system failure 51
Device damaged prior to use 48
Detachment of device or device component 42
Difficult to remove 37
Malposition of device 35
Entrapment of device or device component 32
Material deformation 30
Material Protrusion 29
Buckled material 29
Difficult to deploy 29
Occlusion within device 29
Positioning Issue 28
Mechanical issue 24
Device Difficult to Setup or Prepare 23
Air leak 22
Leak 22
Crack 21
Device, or device fragments remain in patient 21
Size incorrect for patient 20
Device or device component damaged by another device 16
Material rupture 15
No Information 14
Use of Device Issue 14
Difficult or delayed activation 13
Device, removal of (non-implant) 13
Device remains implanted 11
Lens, repositioning of 9
Component(s), broken 9
Not Applicable 9
Structural problem 8
Unintended movement 8
Knotted 8
Therapeutic or diagnostic output failure 7
Dislodged or dislocated 7
Patient-device incompatibility 6
Foreign material present in device 6
Device-device incompatibility 6
Device markings issue 6
Failure to disconnect 5
Difficult to insert 5
Inaccurate delivery 5
Blockage within device or device component 5
Difficult to fold or unfold 5
Unable to confirm conditions of use 5
Material disintegration 5
Material integrity issue 5
Failure to fold 5
Connection issue 4
Component missing 4
Sticking 4
Torn material 4
Device or device fragments location unknown 4
Component falling 4
Defective item 3
Failure to flush 3
Slippage of device or device component 3
Packaging issue 3
Unsealed device packaging 3
Contamination during use 3
Improper or incorrect procedure or method 3
Delivery System Issue, No Description 3
Interference 2
Failure to prime 2
Uncoiled 2
Coiled 2
Material frayed 2
Electrical issue 2
Seal, defective 2
Dislodged 2
Incorrect device or component shipped 2
Peeled 2
Failure to discharge 2
Material perforation 2
Total Device Problems 7675

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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