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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 977
Physical resistance 796
Failure to advance 744
Stretched 701
Detachment of device component 608
Other (for use when an appropriate device code cannot be identified) 570
Premature deployment 543
Failure to deploy 367
Break 363
Unraveled material 267
Kinked 249
Migration of device or device component 192
Mechanical jam 172
Difficult to advance 159
Device handling issue 142
Device Issue 117
Device operates differently than expected 110
No code available 107
Failure to separate 105
Bent 101
Difficult to position 81
Retraction problem 76
Unknown (for use when the device problem is not known) 70
Fracture 69
Out-of-box failure 64
Material separation 63
Deployment issue 57
Device damaged prior to use 54
Delivery system failure 51
Difficult to remove 46
Detachment of device or device component 45
Entrapment of device or device component 40
Material Protrusion 38
Mechanical issue 36
Malposition of device 35
Buckled material 34
Material deformation 34
Difficult to deploy 33
Occlusion within device 29
Positioning Issue 28
Device Difficult to Setup or Prepare 24
Size incorrect for patient 22
Air leak 22
Leak 22
Crack 21
Device, or device fragments remain in patient 21
No Information 19
Difficult or delayed activation 18
Device or device component damaged by another device 17
Material rupture 15
Use of Device Issue 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
Defective item 9
Device markings issue 9
Patient-device incompatibility 8
Structural problem 8
Difficult to insert 8
Failure to fold 8
Knotted 8
Therapeutic or diagnostic output failure 7
Dislodged or dislocated 7
Foreign material present in device 6
Material integrity issue 6
Failure to disconnect 5
Inaccurate delivery 5
Unable to confirm conditions of use 5
Difficult to fold or unfold 5
Material disintegration 5
Blockage within device or device component 5
Component falling 4
Sticking 4
Device or device fragments location unknown 4
Connection issue 4
Component missing 4
Torn material 4
Packaging issue 3
Delivery System Issue, No Description 3
Slippage of device or device component 3
Improper or incorrect procedure or method 3
Unsealed device packaging 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
Uncoiled 2
Total Device Problems 8850

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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