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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, vascular, for promoting embolization
Product CodeKRD
Regulation Number 870.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ABK BIOMEDICAL INC
  SUBSTANTIALLY EQUIVALENT 2
ARTIO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTVENTIVE MEDICAL GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAIT USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOSPHERE MEDICAL, S.A.
  SUBSTANTIALLY EQUIVALENT 5
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
EMBOLIC ACCELERATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU YANGSHUN MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
KA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION INC.
  SUBSTANTIALLY EQUIVALENT 2
OBSIDIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
OKAMI MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
SHAPE MEMORY MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
SUZHOU HAOWEI MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K231554  UniPearls® Embolic Microspheres
SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1066 1066
2019 1185 1185
2020 1167 1167
2021 1444 1444
2022 1498 1498
2023 1374 1374
2024 1040 1040

Device Problems MDRs with this Device Problem Events in those MDRs
Separation Failure 1896 1896
Detachment of Device or Device Component 1419 1419
Stretched 1092 1092
Adverse Event Without Identified Device or Use Problem 849 849
Physical Resistance/Sticking 783 783
Failure to Advance 537 537
Break 468 468
Premature Separation 468 468
Entrapment of Device 375 375
Migration 344 344
Difficult to Advance 308 308
Material Deformation 299 299
Premature Activation 237 237
Material Twisted/Bent 226 226
Difficult to Remove 208 208
Positioning Problem 200 200
Migration or Expulsion of Device 198 198
Unraveled Material 177 177
Deformation Due to Compressive Stress 173 173
Material Separation 122 122
Detachment Of Device Component 109 109
Material Protrusion/Extrusion 108 108
Unintended Movement 95 95
Off-Label Use 94 94
Device-Device Incompatibility 93 93
Device Difficult to Setup or Prepare 89 89
Positioning Failure 82 82
Material Integrity Problem 80 80
Difficult or Delayed Separation 68 68
Packaging Problem 67 67
Patient Device Interaction Problem 63 63
Malposition of Device 62 62
Inadequacy of Device Shape and/or Size 56 56
Activation, Positioning or Separation Problem 54 54
Difficult or Delayed Positioning 52 52
Kinked 50 50
Activation Problem 48 48
Fracture 47 47
Material Rupture 35 35
Difficult to Insert 35 35
Use of Device Problem 31 31
Separation Problem 29 29
Material Split, Cut or Torn 29 29
Product Quality Problem 29 29
No Apparent Adverse Event 28 28
Physical Resistance 25 25
Improper or Incorrect Procedure or Method 24 24
Therapy Delivered to Incorrect Body Area 24 24
Retraction Problem 24 24
Component Missing 22 22

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4509 4509
No Consequences Or Impact To Patient 1619 1620
No Known Impact Or Consequence To Patient 1094 1094
Aneurysm 271 271
No Code Available 181 181
Foreign Body In Patient 156 156
Insufficient Information 104 104
Pain 86 86
Thromboembolism 72 72
Hemorrhage/Bleeding 63 63
Obstruction/Occlusion 62 62
Device Embedded In Tissue or Plaque 61 61
Intracranial Hemorrhage 55 55
Stroke/CVA 53 53
Thrombosis/Thrombus 49 49
Ruptured Aneurysm 46 46
Death 44 44
Embolism/Embolus 43 43
Ischemia Stroke 41 41
Ischemia 38 38
Vasoconstriction 37 37
Abdominal Pain 34 34
No Patient Involvement 34 34
Infarction, Cerebral 32 32
Hematoma 26 26
Fever 25 25
Necrosis 25 25
Inflammation 25 25
Hypersensitivity/Allergic reaction 24 24
Perforation of Vessels 23 23
Therapeutic Response, Decreased 21 21
Thrombosis 20 20
Sepsis 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Unspecified Infection 19 19
Rupture 18 18
Patient Problem/Medical Problem 18 18
Hemorrhage, Subarachnoid 17 17
Fistula 17 17
Low Blood Pressure/ Hypotension 16 16
Paresis 16 16
No Information 16 16
Pseudoaneurysm 16 16
Abscess 15 15
Unspecified Tissue Injury 15 15
Liver Damage/Dysfunction 14 14
Test Result 14 14
Convulsion/Seizure 14 14
Vomiting 14 14
Stenosis 13 13

Recalls
Manufacturer Recall Class Date Posted
1 BALT USA, LLC II Feb-08-2024
2 Boston Scientific Corporation I Mar-27-2024
3 Cook Incorporated II Jun-06-2022
4 MICROVENTION INC. II Oct-27-2023
5 Microvention, Inc. II Feb-13-2020
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