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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 3
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 3
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
STRYKER NEUROVSCULAR
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1753 1753
2021 2267 2267
2022 663 663
2023 569 569
2024 557 557
2025 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 1615 1615
Premature Separation 1571 1571
Failure to Advance 1429 1429
Material Deformation 434 434
Separation Failure 375 375
Fracture 288 288
Adverse Event Without Identified Device or Use Problem 285 285
Detachment of Device or Device Component 279 279
Difficult or Delayed Separation 270 270
Mechanical Problem 216 216
Migration 199 199
Break 142 142
Stretched 131 131
Failure to Fold 108 108
Unraveled Material 85 85
Expulsion 61 61
Difficult to Advance 61 61
Difficult to Remove 38 38
Material Twisted/Bent 28 28
Device Dislodged or Dislocated 23 23
No Apparent Adverse Event 22 22
Component Missing 21 21
Appropriate Term/Code Not Available 18 18
Device-Device Incompatibility 17 17
Positioning Problem 15 15
Migration or Expulsion of Device 13 13
Fluid/Blood Leak 13 13
Difficult or Delayed Positioning 12 12
Insufficient Information 12 12
Separation Problem 12 12
Device Markings/Labelling Problem 10 10
Premature Activation 9 9
Activation Failure 9 9
Activation, Positioning or Separation Problem 9 9
Retraction Problem 9 9
Unintended Movement 8 8
Entrapment of Device 7 7
Inadequacy of Device Shape and/or Size 7 7
Inaccurate Information 6 6
Malposition of Device 5 5
Material Separation 5 5
Device Slipped 4 4
Material Frayed 4 4
Device Difficult to Setup or Prepare 4 4
Poor Visibility 4 4
Corroded 3 3
Deformation Due to Compressive Stress 3 3
Component Misassembled 3 3
Material Split, Cut or Torn 3 3
Unsealed Device Packaging 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4337 4337
No Consequences Or Impact To Patient 1844 1844
Foreign Body In Patient 64 64
Thrombosis/Thrombus 62 62
Aneurysm 50 50
Ruptured Aneurysm 42 42
Ischemia Stroke 41 41
Insufficient Information 39 39
Stroke/CVA 29 29
Hemorrhage/Bleeding 28 28
Intracranial Hemorrhage 26 26
No Known Impact Or Consequence To Patient 21 21
Rupture 20 20
Obstruction/Occlusion 18 18
Headache 17 17
Muscle Weakness 16 16
Thromboembolism 15 15
Hydrocephalus 15 15
Vasoconstriction 14 14
Paresis 12 12
Embolism/Embolus 12 12
Paralysis 11 11
Stenosis 11 11
Hematoma 11 11
Device Embedded In Tissue or Plaque 10 10
Ischemia 10 10
Cerebral Edema 9 9
Visual Impairment 9 9
Swelling/ Edema 8 8
Convulsion/Seizure 8 8
Perforation of Vessels 8 8
Inflammation 8 8
Unspecified Nervous System Problem 8 8
Perforation 7 7
Cognitive Changes 7 7
Extravasation 6 6
Loss of Vision 6 6
Visual Disturbances 6 6
Dysphasia 6 6
Hemorrhagic Stroke 6 6
Neuropathy 5 5
Thrombosis 5 5
Speech Disorder 5 5
Unspecified Infection 5 5
Failure of Implant 5 5
Coma 4 4
Foreign Body Reaction 4 4
Fever 4 4
Death 4 4
Cardiac Arrest 4 4

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 Micro Therapeutics, Inc. II Jun-13-2022
6 Microvention, Inc. II Feb-27-2020
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