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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 29
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 827
Stretched 583
Other (for use when an appropriate device code cannot be identified) 570
Premature deployment 406
Failure to advance 326
Break 275
Physical resistance 261
Detachment of device component 258
Failure to deploy 251
Unraveled material 247
Kinked 141
Migration of device or device component 140
Difficult to advance 132
No code available 103
Device Issue 75
Unknown (for use when the device problem is not known) 70
Failure to separate 61
Fracture 59
Deployment issue 54
Material separation 53
Delivery system failure 51
Difficult to position 40
Bent 37
Retraction problem 35
Difficult to remove 34
Detachment of device or device component 34
Malposition of device 32
Entrapment of device or device component 30
Occlusion within device 29
Device operates differently than expected 28
Out-of-box failure 28
Positioning Issue 28
Device handling issue 27
Mechanical jam 27
Device damaged prior to use 27
Material Protrusion 23
Buckled material 23
Difficult to deploy 22
Leak 22
Crack 21
Device, or device fragments remain in patient 21
Device Difficult to Setup or Prepare 20
Air leak 17
Material deformation 17
Material rupture 15
Use of Device Issue 14
No Information 14
Device or device component damaged by another device 13
Device, removal of (non-implant) 13
Device remains implanted 11
Mechanical issue 9
Component(s), broken 9
Lens, repositioning of 9
Not Applicable 9
Difficult or delayed activation 8
Therapeutic or diagnostic output failure 7
Unintended movement 6
Device markings issue 6
Knotted 6
Size incorrect for patient 6
Difficult to fold or unfold 5
Difficult to insert 5
Unable to confirm conditions of use 5
Dislodged or dislocated 5
Foreign material present in device 5
Inaccurate delivery 5
Failure to disconnect 5
Device or device fragments location unknown 4
Component missing 4
Device-device incompatibility 4
Connection issue 4
Blockage within device or device component 4
Material disintegration 4
Sticking 4
Improper or incorrect procedure or method 3
Contamination during use 3
Component falling 3
Failure to flush 3
Delivery System Issue, No Description 3
Structural problem 3
Torn material 3
Material integrity issue 3
Packaging issue 3
Uncoiled 2
Incorrect device or component shipped 2
Interference 2
Dislodged 2
Electrical issue 2
Failure to discharge 2
Disconnection 2
Coiled 2
Seal, defective 2
Bacterial contamination of device 2
Material perforation 2
Unsealed device packaging 2
Peeled 2
Port leak(s) 1
Failure to power-up 1
Mislabeled 1
Nonstandard device or device component 1
Total Device Problems 5840

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