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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 852
Stretched 592
Other (for use when an appropriate device code cannot be identified) 570
Premature deployment 425
Failure to advance 376
Physical resistance 306
Detachment of device component 302
Break 280
Failure to deploy 273
Unraveled material 247
Kinked 147
Migration of device or device component 147
Difficult to advance 137
No code available 103
Device Issue 92
Unknown (for use when the device problem is not known) 70
Failure to separate 61
Fracture 59
Deployment issue 56
Material separation 54
Delivery system failure 51
Difficult to position 47
Mechanical jam 46
Bent 44
Retraction problem 40
Device handling issue 35
Detachment of device or device component 35
Out-of-box failure 34
Difficult to remove 34
Device damaged prior to use 33
Malposition of device 33
Device operates differently than expected 32
Entrapment of device or device component 31
Occlusion within device 29
Positioning Issue 28
Material Protrusion 25
Difficult to deploy 25
Buckled material 23
Leak 22
Crack 21
Device, or device fragments remain in patient 21
Device Difficult to Setup or Prepare 21
Material deformation 19
Air leak 17
Material rupture 15
Use of Device Issue 14
No Information 14
Device or device component damaged by another device 14
Device, removal of (non-implant) 13
Mechanical issue 11
Device remains implanted 11
Component(s), broken 9
Lens, repositioning of 9
Not Applicable 9
Difficult or delayed activation 8
Size incorrect for patient 8
Therapeutic or diagnostic output failure 7
Unintended movement 6
Device markings issue 6
Dislodged or dislocated 6
Knotted 6
Difficult to fold or unfold 5
Difficult to insert 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
Structural problem 5
Component missing 4
Connection issue 4
Device or device fragments location unknown 4
Torn material 4
Material integrity issue 4
Material disintegration 4
Sticking 4
Improper or incorrect procedure or method 3
Contamination during use 3
Component falling 3
Failure to flush 3
Packaging issue 3
Delivery System Issue, No Description 3
Patient-device incompatibility 2
Uncoiled 2
Seal, defective 2
Bacterial contamination of device 2
Defective item 2
Incorrect device or component shipped 2
Interference 2
Failure to fold 2
Dislodged 2
Electrical issue 2
Failure to discharge 2
Disconnection 2
Coiled 2
Material perforation 2
Unsealed device packaging 2
Peeled 2
Port leak(s) 1
Total Device Problems 6185

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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