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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 543 543

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Advance 3110 3110
Physical Resistance/Sticking 1709 1709
Physical Resistance 1538 1538
Detachment Of Device Component 975 975
Premature Separation 786 786
Adverse Event Without Identified Device or Use Problem 724 724
Separation Failure 560 560
Break 546 546
Material Deformation 473 473
Stretched 460 460
Mechanical Problem 398 398
Kinked 382 382
Detachment of Device or Device Component 367 367
Premature Activation 347 347
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 194 194
Migration or Expulsion of Device 188 188
Bent 165 165
Difficult or Delayed Separation 152 152
Failure to Fold 145 145
Retraction Problem 137 137
Out-Of-Box Failure 130 130
Unraveled Material 122 122
Difficult or Delayed Activation 120 120
Fracture 113 113
Difficult to Remove 112 112
Device Issue 104 104
Difficult To Position 93 93
Migration 93 93
Material Twisted/Bent 86 86
Device-Device Incompatibility 72 72
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 51 51
Material Separation 44 44
Appropriate Term/Code Not Available 38 38
Entrapment of Device 37 37
Positioning Problem 35 35
Unintended Movement 35 35
Device Dislodged or Dislocated 28 28
Insufficient Information 28 28
Device Fell 25 25
Malposition of Device 25 25
Defective Device 24 24
Material Too Rigid or Stiff 22 22
Separation Problem 18 18
Patient-Device Incompatibility 17 17
Device Markings/Labelling Problem 16 16
Expulsion 14 14
Use of Device Problem 14 14
Fluid Leak 14 14
Device Difficult to Setup or Prepare 12 12
Device Operational Issue 12 12
Device Damaged by Another Device 11 11
Material Integrity Problem 11 11
Difficult to Insert 10 10
No Apparent Adverse Event 10 10
Material Frayed 9 9
Knotted 7 7
Sticking 7 7
Device Slipped 7 7
Collapse 6 6
Air Leak 5 5
Component Missing 5 5
Structural Problem 5 5
Contamination 5 5
Device Contamination with Chemical or Other Material 5 5
Defective Component 4 4
Component Misassembled 4 4
Improper or Incorrect Procedure or Method 4 4
Component Falling 4 4
Noise, Audible 4 4
Inadequate User Interface 4 4
Unsealed Device Packaging 4 4
Unintended Ejection 3 3
Crack 3 3
Looping 3 3
Off-Label Use 3 3
Human Factors Issue 3 3
Material Split, Cut or Torn 3 3
Activation Problem 3 3
Physical Property Issue 3 3
Folded 3 3
Difficult to Open or Remove Packaging Material 3 3
Leak/Splash 3 3
Tear, Rip or Hole in Device Packaging 3 3
Failure to Disconnect 3 3
Contamination /Decontamination Problem 3 3
Chemical Problem 2 2
Material Distortion 2 2
Electrical /Electronic Property Problem 2 2
Accessory Incompatible 2 2
Misconnection 2 2
Peeled/Delaminated 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 8308 8308
No Clinical Signs, Symptoms or Conditions 1145 1145
No Patient Involvement 474 474
No Known Impact Or Consequence To Patient 386 386
Aneurysm 260 260
Headache 122 122
Thrombus 109 109
Hemorrhage, Subarachnoid 101 101
Neurological Deficit/Dysfunction 80 80
Thrombosis 74 74
Stroke/CVA 67 67
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
Foreign Body In Patient 18 18
No Information 17 17
Nausea 17 17
Vasoconstriction 17 17
Perforation 16 16
Unspecified Infection 16 16
Dysphasia 14 14
Hydrocephalus 14 14
Fever 14 14
Abdominal Pain 13 13
Pain 12 12
Injury 12 12
Thromboembolism 12 12
Hematoma 12 12
Perforation of Vessels 12 12
Inflammation 11 11
High Blood Pressure/ Hypertension 10 10
Paresis 10 10
Embolism 10 10
Necrosis 9 9
Extravasation 9 9
Vitreous Floaters 8 8
Blood Loss 8 8
Dizziness 7 7
Embolus 7 7
Thrombosis/Thrombus 7 7
Lethargy 6 6
Abscess 6 6
Edema 6 6
Liver Damage/Dysfunction 6 6
Vascular System (Circulation), Impaired 6 6
Ascites 6 6
Ruptured Aneurysm 6 6
Foreign Body Reaction 5 5
Insufficient Information 5 5
Neck Pain 5 5
Numbness 4 4
Ulcer 4 4
Vessel Or Plaque, Device Embedded In 4 4
Encephalopathy 4 4
Neuropathy 4 4
Pneumonia 4 4
Stenosis 4 4
Therapeutic Response, Decreased 3 3
Seizures 3 3
Obstruction/Occlusion 3 3
Fistula 3 3
Chest Pain 3 3
Bacterial Infection 3 3
Low Blood Pressure/ Hypotension 3 3
Fatigue 3 3
Pulmonary Embolism 3 3
Toxicity 3 3
Cancer 3 3
Rash 2 2
Sepsis 2 2
Septic Shock 2 2
Swelling 2 2
Pulmonary Emphysema 2 2
Gangrene 2 2
Hepatitis 2 2
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
Ptosis 2 2
Visual Impairment 2 2
Brain Injury 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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