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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 818
Stretched 577
Other (for use when an appropriate device code cannot be identified) 570
Premature deployment 387
Failure to advance 270
Break 260
Failure to deploy 245
Unraveled material 244
Detachment of device component 217
Physical resistance 215
Kinked 132
Difficult to advance 129
Migration of device or device component 128
No code available 103
Unknown (for use when the device problem is not known) 70
Fracture 58
Failure to separate 57
Deployment issue 51
Material separation 51
Delivery system failure 50
Device Issue 48
Difficult to position 36
Difficult to remove 34
Malposition of device 30
Retraction problem 29
Occlusion within device 29
Bent 29
Detachment of device or device component 28
Entrapment of device or device component 27
Device operates differently than expected 25
Positioning Issue 25
Out-of-box failure 24
Material Protrusion 22
Leak 22
Device damaged prior to use 22
Device, or device fragments remain in patient 21
Crack 21
Difficult to deploy 21
Buckled material 21
Device Difficult to Setup or Prepare 20
Device handling issue 19
Material deformation 17
Air leak 17
Material rupture 15
No Information 14
Device, removal of (non-implant) 13
Device or device component damaged by another device 12
Use of Device Issue 12
Device remains implanted 11
Component(s), broken 9
Lens, repositioning of 9
Not Applicable 9
Mechanical jam 8
Mechanical issue 8
Therapeutic or diagnostic output failure 7
Difficult or delayed activation 7
Device markings issue 6
Unintended movement 6
Knotted 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
Failure to disconnect 5
Inaccurate delivery 5
Device or device fragments location unknown 4
Device-device incompatibility 4
Connection issue 4
Blockage within device or device component 4
Material disintegration 4
Size incorrect for patient 4
Sticking 4
Improper or incorrect procedure or method 3
Component falling 3
Contamination during use 3
Failure to flush 3
Delivery System Issue, No Description 3
Component missing 3
Structural problem 3
Material integrity issue 3
Torn material 3
Packaging issue 3
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
Uncoiled 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 5494

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 1
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 Apr-19-2016
8 Stryker Neurovascular II Dec-16-2014
9 Stryker Neurovascular II Dec-13-2013

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