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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
Product CodeHCG
Regulation Number 882.5950
Device Class 2


Premarket Reviews
ManufacturerDecision
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
BIOCOMPATIBLES U.K. LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BIOSPHERE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BLOCKADE MEDICAL
  SUBSTANTIALLY EQUIVALENT 6
BLOCKADE MEDICAL, LLC (D.B.A. BALT USA)
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 5
CODMAN & SHURTLEFF, INC
  SUBSTANTIALLY EQUIVALENT 2
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 5
CODMAN AND SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
KANEKA MEDICAL AMERICA LLC
  SUBSTANTIALLY EQUIVALENT 1
KANEKA PHARMA AMERICA LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 4
MICRO THERAPEUTICS, LNC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT NEUROTECH (SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MICROVENTION, INC
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 20
MICRUS ENDOVASCULAR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 10
SPARTAN MICRO, INC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 9
STRYKER NEUROVSCULAR
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1729 1729
2015 1598 1598
2016 1990 1990
2017 2494 2494
2018 2058 2058
2019 1763 1763
2020 1753 1753
2021 2267 2267
2022 663 663
2023 569 569
2024 387 387

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Advance 4073 4073
Physical Resistance/Sticking 2484 2484
Premature Separation 1877 1877
Physical Resistance 1873 1873
Detachment Of Device Component 1357 1357
Adverse Event Without Identified Device or Use Problem 1235 1235
Stretched 894 894
Separation Failure 867 867
Break 850 850
Material Deformation 711 711
Premature Activation 661 661
Positioning Failure 660 660
Kinked 649 649
Detachment of Device or Device Component 594 594
Mechanical Problem 516 516
Difficult to Advance 377 377
Device Operates Differently Than Expected 376 376
Fracture 359 359
Difficult or Delayed Separation 328 328
Mechanical Jam 316 316
Migration or Expulsion of Device 302 302
Device Handling Problem 294 294
Device Damaged Prior to Use 259 259
Bent 246 246
Migration 239 239
Unraveled Material 217 217
Difficult to Remove 202 202
Failure to Fold 200 200
Retraction Problem 193 193
Out-Of-Box Failure 146 146
Difficult To Position 134 134
Insufficient Information 131 131
Device Issue 130 130
Difficult or Delayed Activation 123 123
Activation, Positioning or Separation Problem 100 100
Material Twisted/Bent 97 97
Device-Device Incompatibility 93 93
Deformation Due to Compressive Stress 92 92
Material Separation 86 86
Inadequacy of Device Shape and/or Size 85 85
Positioning Problem 83 83
Difficult or Delayed Positioning 79 79
Entrapment of Device 77 77
Material Protrusion/Extrusion 77 77
Appropriate Term/Code Not Available 73 73
No Apparent Adverse Event 59 59
Sticking 58 58
Device Dislodged or Dislocated 55 55
Malposition of Device 54 54
Expulsion 53 53

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 9944 9944
No Clinical Signs, Symptoms or Conditions 4171 4171
No Known Impact Or Consequence To Patient 1420 1420
No Patient Involvement 542 542
Aneurysm 381 381
Headache 149 149
Death 140 140
Stroke/CVA 136 136
Hemorrhage, Subarachnoid 128 128
Thrombus 127 127
Rupture 114 114
Neurological Deficit/Dysfunction 109 109
Thrombosis 105 105
Device Embedded In Tissue or Plaque 92 92
Hemorrhage/Bleeding 87 87
Foreign Body In Patient 79 79
Infarction, Cerebral 71 71
Transient Ischemic Attack 65 65
Weakness 65 65
No Code Available 64 64
Intracranial Hemorrhage 60 60
Ischemia 54 54
Thrombosis/Thrombus 54 54
Visual Disturbances 44 44
Hemorrhage, Cerebral 43 43
Abdominal Pain 41 41
Ruptured Aneurysm 41 41
Ischemia Stroke 40 40
Insufficient Information 39 39
No Information 39 39
Vasoconstriction 38 38
Occlusion 37 37
Thromboembolism 36 36
Pain 36 36
Reaction 34 34
Perforation 34 34
Hydrocephalus 33 33
Fever 33 33
Vomiting 29 29
Nausea 27 27
Paresis 27 27
Unspecified Infection 26 26
Hematoma 26 26
Inflammation 25 25
Abscess 24 24
Dysphasia 24 24
Patient Problem/Medical Problem 24 24
Extravasation 21 21
Injury 21 21
Therapeutic Response, Decreased 20 20

Recalls
Manufacturer Recall Class Date Posted
1 BALT USA, LLC II Feb-08-2024
2 BALT USA, LLC II Oct-20-2022
3 BALT USA, LLC II Sep-06-2022
4 BALT USA, LLC II Feb-22-2022
5 Codman & Shurtleff Inc II Aug-15-2019
6 Micro Therapeutics Inc, dba ev3 Neurovascular III Jan-26-2012
7 Micro Therapeutics Inc, dba ev3 Neurovascular III Jan-24-2012
8 Micro Therapeutics, Inc. II Jun-13-2022
9 Microvention, Inc. II Feb-27-2020
10 Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131 II Jan-03-2011
11 Penumbra Inc. I Apr-12-2011
12 Stryker Neurovascular II Jul-11-2016
13 Stryker Neurovascular II Apr-19-2016
14 Stryker Neurovascular II Dec-16-2014
15 Stryker Neurovascular II Dec-13-2013
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