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

MDR Year MDR Reports MDR Events
2017 2494 2494
2018 2058 2058
2019 1763 1763
2020 1753 1753
2021 2267 2267
2022 311 311

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Advance 3243 3243
Physical Resistance/Sticking 2271 2271
Premature Separation 1193 1193
Physical Resistance 1078 1078
Separation Failure 687 687
Material Deformation 635 635
Adverse Event Without Identified Device or Use Problem 601 601
Detachment Of Device Component 583 583
Mechanical Problem 481 481
Break 465 465
Detachment of Device or Device Component 438 438
Stretched 360 360
Difficult or Delayed Separation 269 269
Kinked 267 267
Device Handling Problem 211 211
Device Operates Differently Than Expected 208 208
Device Damaged Prior to Use 202 202
Mechanical Jam 191 191
Failure to Fold 180 180
Premature Activation 176 176
Fracture 166 166
Difficult to Advance 158 158
Migration 151 151
Positioning Failure 132 132
Migration or Expulsion of Device 119 119
Unraveled Material 116 116
Difficult or Delayed Activation 110 110
Difficult to Remove 109 109
Bent 97 97
Retraction Problem 94 94
Material Twisted/Bent 93 93
Out-Of-Box Failure 90 90
Device-Device Incompatibility 78 78
Difficult To Position 54 54
Material Protrusion/Extrusion 47 47
Inadequacy of Device Shape and/or Size 44 44
Difficult or Delayed Positioning 43 43
Appropriate Term/Code Not Available 43 43
Device Dislodged or Dislocated 35 35
Deformation Due to Compressive Stress 31 31
Unintended Movement 31 31
Material Separation 31 31
Positioning Problem 29 29
Device Fell 25 25
Entrapment of Device 25 25
Material Too Rigid or Stiff 22 22
Separation Problem 22 22
Expulsion 22 22
Activation, Positioning or SeparationProblem 22 22
Defective Device 21 21
Insufficient Information 20 20
Device Markings/Labelling Problem 16 16
Malposition of Device 15 15
Fluid Leak 15 15
No Apparent Adverse Event 12 12
Patient-Device Incompatibility 11 11
Component Missing 11 11
Material Integrity Problem 9 9
Material Frayed 8 8
Difficult to Insert 7 7
Device Difficult to Setup or Prepare 7 7
Collapse 6 6
Activation Failure 6 6
Component Misassembled 5 5
Inadequate User Interface 5 5
Difficult to Open or Remove Packaging Material 4 4
Device Damaged by Another Device 4 4
Material Split, Cut or Torn 4 4
Noise, Audible 4 4
Knotted 4 4
Device Slipped 4 4
Defective Component 4 4
Tear, Rip or Hole in Device Packaging 3 3
Folded 3 3
Sticking 3 3
Leak/Splash 3 3
Unsealed Device Packaging 3 3
Contamination 3 3
Unintended Ejection 3 3
Activation Problem 3 3
Contamination /Decontamination Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Physical Property Issue 3 3
Chemical Problem 2 2
Device Operational Issue 2 2
Electrical Overstress 2 2
Crack 2 2
Accessory Incompatible 2 2
Misconnection 2 2
Looping 2 2
Material Fragmentation 2 2
Use of Device Problem 2 2
Off-Label Use 2 2
Peeled/Delaminated 2 2
Split 2 2
Dull, Blunt 1 1
Incomplete or Missing Packaging 1 1
Device Contamination with Body Fluid 1 1
Wrinkled 1 1
High Sensing Threshold 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 6888 6888
No Clinical Signs, Symptoms or Conditions 3071 3071
No Patient Involvement 377 377
No Known Impact Or Consequence To Patient 297 297
Headache 124 124
Aneurysm 100 100
Thrombus 78 78
Neurological Deficit/Dysfunction 61 61
Rupture 48 48
Thrombosis 47 47
Ischemia 40 40
Death 40 40
Hemorrhage, Subarachnoid 37 37
Weakness 37 37
Visual Disturbances 36 36
Stroke/CVA 35 35
Device Embedded In Tissue or Plaque 31 31
Hemorrhage/Bleeding 30 30
Infarction, Cerebral 28 28
Hemorrhage, Cerebral 26 26
Reaction 25 25
Ischemia Stroke 22 22
Thrombosis/Thrombus 21 21
Foreign Body In Patient 21 21
Thromboembolism 20 20
Intracranial Hemorrhage 20 20
Insufficient Information 19 19
Vasoconstriction 17 17
Ruptured Aneurysm 16 16
No Code Available 16 16
Transient Ischemic Attack 15 15
Patient Problem/Medical Problem 14 14
Unspecified Infection 13 13
Occlusion 13 13
No Information 12 12
Perforation of Vessels 12 12
Vomiting 12 12
Injury 11 11
Hydrocephalus 11 11
Nausea 11 11
Fever 11 11
Inflammation 10 10
Paresis 10 10
Perforation 10 10
Hematoma 9 9
Pain 8 8
Vitreous Floaters 8 8
Embolism 8 8
Dizziness 8 8
Dysphasia 7 7
Visual Impairment 7 7
Embolus 7 7
Foreign Body Reaction 6 6
Extravasation 6 6
High Blood Pressure/ Hypertension 6 6
Convulsion/Seizure 6 6
Lethargy 6 6
Blood Loss 5 5
Embolism/Embolus 5 5
Cognitive Changes 5 5
Obstruction/Occlusion 5 5
Neck Pain 5 5
Muscle Weakness 5 5
Abscess 5 5
Abdominal Pain 4 4
Neuropathy 4 4
Liver Damage/Dysfunction 4 4
Numbness 4 4
Stenosis 4 4
Vascular System (Circulation), Impaired 4 4
Cramp(s) /Muscle Spasm(s) 3 3
Therapeutic Response, Decreased 3 3
Hemoptysis 3 3
Necrosis 3 3
Fatigue 3 3
Edema 3 3
Cardiac Arrest 2 2
Pulmonary Emphysema 2 2
Chest Pain 2 2
Diarrhea 2 2
Bacterial Infection 2 2
Low Blood Pressure/ Hypotension 2 2
Brain Injury 2 2
Swelling/ Edema 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Gastrointestinal Hemorrhage 2 2
Unspecified Nervous System Problem 2 2
Cerebral Edema 2 2
Ascites 2 2
Toxicity 2 2
Vaso-Vagal Response 1 1
Decreased Sensitivity 1 1
Multiple Organ Failure 1 1
Nervous System Injury 1 1
Vascular Dissection 1 1
Constipation 1 1
Foreign Body Embolism 1 1
Cough 1 1
Respiratory Insufficiency 1 1
Convulsion, Clonic 1 1

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