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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
BLOCKADE MEDICAL, LLC (D.B.A. BALT USA)
  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 1
MICRO THERAPEUTICS, LNC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT NEUROTECH (SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPARTAN MICRO, INC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
WALLABY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2058 2058
2019 1763 1763
2020 1753 1753
2021 2267 2267
2022 663 663
2023 513 513

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Advance 2587 2587
Physical Resistance/Sticking 2414 2414
Premature Separation 1646 1646
Material Deformation 646 646
Separation Failure 566 566
Detachment of Device or Device Component 473 473
Mechanical Problem 384 384
Break 376 376
Adverse Event Without Identified Device or Use Problem 375 375
Physical Resistance 330 330
Difficult or Delayed Separation 320 320
Fracture 235 235
Stretched 215 215
Detachment Of Device Component 208 208
Migration 202 202
Failure to Fold 183 183
Device Damaged Prior to Use 147 147
Unraveled Material 107 107
Difficult to Advance 102 102
Material Twisted/Bent 94 94
Kinked 90 90
Difficult to Remove 83 83
Device Handling Problem 82 82
Mechanical Jam 79 79
Difficult or Delayed Activation 60 60
Device Operates Differently Than Expected 54 54
Device-Device Incompatibility 52 52
Premature Activation 52 52
Migration or Expulsion of Device 50 50
Retraction Problem 47 47
Expulsion 44 44
Device Dislodged or Dislocated 36 36
Out-Of-Box Failure 36 36
Difficult or Delayed Positioning 34 34
Inadequacy of Device Shape and/or Size 32 32
Bent 29 29
Positioning Problem 26 26
No Apparent Adverse Event 26 26
Device Fell 25 25
Appropriate Term/Code Not Available 24 24
Unintended Movement 22 22
Separation Problem 22 22
Deformation Due to Compressive Stress 21 21
Positioning Failure 20 20
Activation, Positioning or Separation Problem 16 16
Component Missing 16 16
Material Protrusion/Extrusion 16 16
Fluid/Blood Leak 15 15
Insufficient Information 14 14
Device Markings/Labelling Problem 13 13
Material Separation 13 13
Material Too Rigid or Stiff 13 13
Difficult To Position 13 13
Malposition of Device 11 11
Entrapment of Device 11 11
Activation Failure 9 9
Defective Device 8 8
Patient-Device Incompatibility 7 7
Collapse 6 6
Material Frayed 6 6
Device Difficult to Setup or Prepare 5 5
Component Misassembled 5 5
Inadequate User Interface 5 5
Material Split, Cut or Torn 4 4
Activation Problem 4 4
Poor Visibility 4 4
Inaccurate Information 4 4
Device Slipped 4 4
Folded 3 3
Contamination /Decontamination Problem 3 3
Leak/Splash 3 3
Contamination 3 3
Corroded 3 3
Device Contamination with Chemical or Other Material 3 3
Material Integrity Problem 3 3
Difficult to Open or Remove Packaging Material 2 2
Noise, Audible 2 2
Physical Property Issue 2 2
Knotted 2 2
Material Fragmentation 2 2
Particulates 2 2
Chemical Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 1 1
Device Contamination with Body Fluid 1 1
Sticking 1 1
Failure to Read Input Signal 1 1
Failure to Select Signal 1 1
Material Rupture 1 1
Self-Activation or Keying 1 1
Dull, Blunt 1 1
High Sensing Threshold 1 1
Wrinkled 1 1
Biocompatibility 1 1
Peeled/Delaminated 1 1
Off-Label Use 1 1
Poor Quality Image 1 1
Unintended Collision 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 5031 5031
No Clinical Signs, Symptoms or Conditions 3803 3803
No Patient Involvement 240 240
No Known Impact Or Consequence To Patient 175 175
Aneurysm 75 75
Thrombosis/Thrombus 46 46
Rupture 41 41
Thrombus 36 36
Insufficient Information 35 35
Foreign Body In Patient 33 33
Ischemia Stroke 33 33
Intracranial Hemorrhage 33 33
Headache 32 32
Ruptured Aneurysm 32 32
Stroke/CVA 29 29
Device Embedded In Tissue or Plaque 27 27
Ischemia 26 26
Hemorrhage/Bleeding 24 24
Thrombosis 23 23
Death 19 19
Thromboembolism 17 17
Obstruction/Occlusion 16 16
Vasoconstriction 14 14
Neurological Deficit/Dysfunction 14 14
Weakness 13 13
Patient Problem/Medical Problem 12 12
Muscle Weakness 12 12
Unspecified Infection 12 12
Perforation 12 12
Paresis 11 11
Hematoma 11 11
Embolism/Embolus 10 10
Stenosis 10 10
Perforation of Vessels 9 9
Infarction, Cerebral 9 9
Occlusion 9 9
Hemorrhage, Subarachnoid 9 9
Fever 8 8
Dizziness 8 8
Unspecified Nervous System Problem 8 8
Hydrocephalus 8 8
Convulsion/Seizure 8 8
No Code Available 8 8
Cerebral Edema 7 7
Swelling/ Edema 7 7
Visual Impairment 7 7
Cognitive Changes 7 7
Inflammation 7 7
Neuropathy 7 7
High Blood Pressure/ Hypertension 6 6
Transient Ischemic Attack 6 6
Cardiac Arrest 6 6
Injury 6 6
Visual Disturbances 6 6
Dysphasia 6 6
Numbness 5 5
Lethargy 5 5
No Information 5 5
Extravasation 5 5
Paralysis 5 5
Hemorrhage, Cerebral 4 4
Fistula 4 4
Foreign Body Reaction 4 4
Abscess 4 4
Hemorrhagic Stroke 4 4
Loss of Vision 4 4
Blood Loss 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Aspiration/Inhalation 3 3
Embolism 3 3
Embolus 3 3
Pain 3 3
Necrosis 3 3
Fatigue 2 2
Nausea 2 2
Failure of Implant 2 2
Shock 2 2
Pulmonary Emphysema 2 2
Hemoptysis 2 2
Bacterial Infection 2 2
Abdominal Pain 2 2
Cyst(s) 2 2
Gastrointestinal Hemorrhage 2 2
Heart Failure/Congestive Heart Failure 2 2
Vascular Dissection 2 2
Speech Disorder 2 2
Pseudoaneurysm 2 2
Coma 2 2
Great Vessel Perforation 2 2
Therapeutic Response, Decreased 2 2
Discomfort 1 1
Brain Injury 1 1
Convulsion, Clonic 1 1
Hernia 1 1
Radiation Sickness Syndrome 1 1
Vomiting 1 1
Blurred Vision 1 1
Loss of consciousness 1 1
Irritability 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BALT USA, LLC II Oct-20-2022
2 BALT USA, LLC II Sep-06-2022
3 BALT USA, LLC II Feb-22-2022
4 Codman & Shurtleff Inc II Aug-15-2019
5 Micro Therapeutics, Inc. II Jun-13-2022
6 Microvention, Inc. II Feb-27-2020
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