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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 859
Stretched 597
Other (for use when an appropriate device code cannot be identified) 570
Premature deployment 435
Failure to advance 431
Physical resistance 372
Detachment of device component 339
Failure to deploy 296
Break 295
Unraveled material 249
Kinked 160
Migration of device or device component 157
Difficult to advance 142
Device Issue 110
No code available 103
Unknown (for use when the device problem is not known) 70
Mechanical jam 69
Failure to separate 63
Fracture 60
Material separation 56
Deployment issue 56
Bent 54
Difficult to position 51
Delivery system failure 51
Device handling issue 46
Device operates differently than expected 44
Retraction problem 44
Out-of-box failure 38
Detachment of device or device component 37
Difficult to remove 36
Device damaged prior to use 35
Malposition of device 33
Entrapment of device or device component 31
Occlusion within device 29
Positioning Issue 28
Material Protrusion 27
Difficult to deploy 26
Buckled material 23
Material deformation 22
Leak 22
Air leak 22
Crack 21
Device, or device fragments remain in patient 21
Device Difficult to Setup or Prepare 21
Material rupture 15
Device or device component damaged by another device 15
No Information 14
Use of Device Issue 14
Mechanical issue 14
Device, removal of (non-implant) 13
Device remains implanted 11
Size incorrect for patient 10
Difficult or delayed activation 10
Not Applicable 9
Component(s), broken 9
Lens, repositioning of 9
Unintended movement 7
Therapeutic or diagnostic output failure 7
Structural problem 6
Device markings issue 6
Dislodged or dislocated 6
Knotted 6
Difficult to insert 5
Difficult to fold or unfold 5
Blockage within device or device component 5
Foreign material present in device 5
Device-device incompatibility 5
Unable to confirm conditions of use 5
Inaccurate delivery 5
Failure to disconnect 5
Material integrity issue 5
Torn material 4
Component missing 4
Patient-device incompatibility 4
Connection issue 4
Device or device fragments location unknown 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
Packaging issue 3
Incorrect device or component shipped 2
Uncoiled 2
Seal, defective 2
Bacterial contamination of device 2
Defective item 2
Failure to fold 2
Interference 2
Material frayed 2
Dislodged 2
Electrical issue 2
Failure to discharge 2
Disconnection 2
Coiled 2
Material perforation 2
Unsealed device packaging 2
Peeled 2
Total Device Problems 6555

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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