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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
  SUBSTANTIALLY EQUIVALENT 1
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
  1.  K232934  Sunsphere
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
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 1152 1152

Device Problems MDRs with this Device Problem Events in those MDRs
Separation Failure 1914 1914
Detachment of Device or Device Component 1428 1428
Stretched 1111 1111
Adverse Event Without Identified Device or Use Problem 860 860
Physical Resistance/Sticking 801 801
Failure to Advance 544 544
Premature Separation 491 491
Break 476 476
Entrapment of Device 375 375
Migration 346 346
Difficult to Advance 312 312
Material Deformation 302 302
Premature Activation 240 240
Material Twisted/Bent 226 226
Difficult to Remove 208 208
Positioning Problem 201 201
Migration or Expulsion of Device 199 199
Unraveled Material 179 179
Deformation Due to Compressive Stress 173 173
Material Separation 124 124
Detachment Of Device Component 109 109
Material Protrusion/Extrusion 108 108
Unintended Movement 97 97
Off-Label Use 96 96
Device-Device Incompatibility 93 93
Device Difficult to Setup or Prepare 90 90
Positioning Failure 82 82
Material Integrity Problem 82 82
Difficult or Delayed Separation 73 73
Packaging Problem 68 68
Patient Device Interaction Problem 66 66
Malposition of Device 64 64
Inadequacy of Device Shape and/or Size 57 57
Activation, Positioning or Separation Problem 54 54
Difficult or Delayed Positioning 53 53
Activation Problem 51 51
Kinked 50 50
Fracture 47 47
Difficult to Insert 35 35
Material Rupture 35 35
Use of Device Problem 32 32
Material Split, Cut or Torn 31 31
Separation Problem 30 30
No Apparent Adverse Event 30 30
Product Quality Problem 30 30
Improper or Incorrect Procedure or Method 25 25
Physical Resistance 25 25
Therapy Delivered to Incorrect Body Area 24 24
Retraction Problem 24 24
Component Missing 23 23

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4604 4604
No Consequences Or Impact To Patient 1619 1620
No Known Impact Or Consequence To Patient 1094 1094
Aneurysm 272 272
No Code Available 181 181
Foreign Body In Patient 161 161
Insufficient Information 111 111
Pain 86 86
Thromboembolism 72 72
Obstruction/Occlusion 64 64
Hemorrhage/Bleeding 63 63
Device Embedded In Tissue or Plaque 61 61
Intracranial Hemorrhage 55 55
Thrombosis/Thrombus 54 54
Stroke/CVA 53 53
Ruptured Aneurysm 47 47
Embolism/Embolus 44 44
Death 44 44
Ischemia Stroke 41 41
Vasoconstriction 39 39
Ischemia 38 38
Abdominal Pain 35 35
No Patient Involvement 34 34
Infarction, Cerebral 32 32
Hematoma 26 26
Necrosis 26 26
Inflammation 25 25
Fever 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
Patient Problem/Medical Problem 18 18
Rupture 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
Failure of Implant 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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