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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
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON PROFESSIONALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KANEKA CORP.
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 3
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2016 1990 1990
2017 2494 2494
2018 2058 2058
2019 1763 1763
2020 1753 1753
2021 147 147

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Advance 2951 2951
Physical Resistance/Sticking 1593 1593
Physical Resistance 1538 1538
Detachment Of Device Component 975 975
Premature Separation 729 729
Adverse Event Without Identified Device or Use Problem 719 719
Coil 540 540
Break 539 539
Separation Failure 532 532
Stretched 452 452
Material Deformation 439 439
Kinked 382 382
Mechanical Problem 379 379
Premature Activation 347 347
Detachment of Device or Device Component 346 346
Mechanical Jam 310 310
Device Handling Problem 285 285
Positioning Failure 275 275
Device Operates Differently Than Expected 274 274
Device Damaged Prior to Use 239 239
Difficult to Advance 189 189
Migration or Expulsion of Device 186 186
Bent 165 165
Failure to Fold 139 139
Retraction Problem 136 136
Out-Of-Box Failure 130 130
Difficult or Delayed Separation 129 129
Unraveled Material 121 121
Difficult or Delayed Activation 120 120
Difficult to Remove 108 108
Device Issue 104 104
Fracture 99 99
Difficult To Position 93 93
Migration 84 84
Material Twisted/Bent 83 83
Device-Device Incompatibility 71 71
Inadequacy of Device Shape and/or Size 61 61
Material Protrusion/Extrusion 59 59
Activation, Positioning or SeparationProblem 56 56
Deformation Due to Compressive Stress 53 53
Difficult or Delayed Positioning 50 50
Material Separation 44 44
Appropriate Term/Code Not Available 38 38
Entrapment of Device 37 37
Positioning Problem 35 35
Unintended Movement 34 34
Insufficient Information 28 28
Device Dislodged or Dislocated 28 28
Malposition of Device 25 25
Device Fell 25 25
Defective Device 24 24
Material Too Rigid or Stiff 22 22
Separation Problem 18 18
Patient-Device Incompatibility 17 17
Use of Device Problem 14 14
Device Markings/Labelling Problem 13 13
Expulsion 13 13
Device Operational Issue 12 12
Device Damaged by Another Device 11 11
Material Integrity Problem 11 11
Device Difficult to Setup or Prepare 11 11
Fluid Leak 11 11
Difficult to Insert 10 10
No Apparent Adverse Event 10 10
Material Frayed 9 9
Sticking 7 7
Knotted 7 7
Collapse 6 6
Device Slipped 6 6
Contamination 5 5
Air Leak 5 5
Device Contamination with Chemical or Other Material 5 5
Component Missing 5 5
Structural Problem 5 5
Noise, Audible 4 4
Component Misassembled 4 4
Component Falling 4 4
Improper or Incorrect Procedure or Method 4 4
Defective Component 4 4
Unsealed Device Packaging 4 4
Off-Label Use 3 3
Hub 3 3
Unintended Ejection 3 3
Leak/Splash 3 3
Looping 3 3
Activation Problem 3 3
Physical Property Issue 3 3
Human Factors Issue 3 3
Inadequate User Interface 3 3
Tear, Rip or Hole in Device Packaging 3 3
Folded 3 3
Failure to Disconnect 3 3
Difficult to Open or Remove Packaging Material 3 3
Contamination /Decontamination Problem 3 3
Chemical Problem 2 2
Electrical Overstress 2 2
Split 2 2
Material Distortion 2 2
Torn Material 2 2
Catheter 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 8156 8156
No Clinical Signs, Symptoms or Conditions 762 762
No Patient Involvement 474 474
No Known Impact Or Consequence To Patient 386 386
Aneurysm 259 259
Headache 122 122
Thrombus 109 109
Hemorrhage, Subarachnoid 101 101
Neurological Deficit/Dysfunction 80 80
Thrombosis 74 74
Stroke/CVA 66 66
Death 63 63
Rupture 58 58
Weakness 55 55
Device Embedded In Tissue or Plaque 55 55
Transient Ischemic Attack 43 43
Ischemia 43 43
Hemorrhage/Bleeding 36 36
Visual Disturbances 35 35
Hemorrhage, Cerebral 32 32
Infarction, Cerebral 32 32
No Code Available 30 30
Intracranial Hemorrhage 26 26
Reaction 25 25
Patient Problem/Medical Problem 24 24
Occlusion 20 20
Vomiting 19 19
Nausea 17 17
No Information 17 17
Foreign Body In Patient 17 17
Unspecified Infection 16 16
Vasoconstriction 15 15
Perforation 15 15
Fever 14 14
Dysphasia 14 14
Abdominal Pain 13 13
Hydrocephalus 13 13
Pain 12 12
Injury 12 12
Thromboembolism 12 12
Hematoma 12 12
Inflammation 11 11
Perforation of Vessels 11 11
High Blood Pressure/ Hypertension 10 10
Paresis 10 10
Embolism 10 10
Necrosis 9 9
Blood Loss 8 8
Vitreous Floaters 8 8
Extravasation 8 8
Dizziness 7 7
Embolus 7 7
Edema 6 6
Liver Damage/Dysfunction 6 6
Vascular System (Circulation), Impaired 6 6
Ascites 6 6
Abscess 6 6
Lethargy 6 6
Thrombosis/Thrombus 5 5
Neck Pain 5 5
Foreign Body Reaction 5 5
Ruptured Aneurysm 5 5
Pneumonia 4 4
Stenosis 4 4
Numbness 4 4
Ulcer 4 4
Vessel Or Plaque, Device Embedded In 4 4
Encephalopathy 4 4
Neuropathy 4 4
Low Blood Pressure/ Hypotension 3 3
Fatigue 3 3
Pulmonary Embolism 3 3
Toxicity 3 3
Insufficient Information 3 3
Cancer 3 3
Therapeutic Response, Decreased 3 3
Seizures 3 3
Fistula 3 3
Chest Pain 3 3
Bacterial Infection 3 3
Biliary Cirrhosis 2 2
Cardiac Arrest 2 2
Diarrhea 2 2
Purulent Discharge 2 2
Disseminated Intravascular Coagulation (DIC) 2 2
Facial Nerve Paralysis 2 2
Hair Loss 2 2
Respiratory Distress 2 2
Paralysis 2 2
Visual Impairment 2 2
Brain Injury 2 2
Ptosis 2 2
Obstruction/Occlusion 2 2
Cerebral Edema 2 2
Rash 2 2
Sepsis 2 2
Septic Shock 2 2
Swelling 2 2
Pulmonary Emphysema 2 2
Gangrene 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Codman & Shurtleff Inc II Aug-15-2019
2 Microvention, Inc. II Feb-27-2020
3 Stryker Neurovascular II Jul-11-2016
4 Stryker Neurovascular II Apr-19-2016
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