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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filter, intravascular, cardiovascular
Regulation Description Cardiovascular intravascular filter.
Product CodeDTK
Regulation Number 870.3375
Device Class 2


Premarket Reviews
ManufacturerDecision
ALN S.A.R.L.
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
B.BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BD
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 5357 5516
2022 2191 2196
2023 583 583
2024 406 406
2025 438 438
2026 141 141

Device Problems MDRs with this Device Problem Events in those MDRs
Structural Problem 3577 3577
Device Tipped Over 1738 1738
Appropriate Term/Code Not Available 1403 1403
Unintended Movement 1256 1255
Detachment of Device or Device Component 1049 1054
Difficult to Remove 1022 1029
Obstruction of Flow 894 894
Patient-Device Incompatibility 868 967
Malposition of Device 708 758
Fracture 446 446
Migration 372 374
Adverse Event Without Identified Device or Use Problem 340 340
Activation Failure 299 299
Patient Device Interaction Problem 295 346
Inadequate Filtration Process 221 221
Insufficient Information 204 204
Positioning Problem 176 178
Migration or Expulsion of Device 176 178
Failure to Advance 163 163
Material Deformation 157 159
Improper or Incorrect Procedure or Method 102 102
Break 86 86
Therapeutic or Diagnostic Output Failure 73 73
Difficult or Delayed Activation 67 67
Activation Problem 61 61
Activation, Positioning or Separation Problem 54 54
Material Puncture/Hole 53 53
Deformation Due to Compressive Stress 52 52
Premature Activation 50 50
Entrapment of Device 48 48
Difficult to Advance 48 48
Difficult to Insert 47 47
Failure to Unfold or Unwrap 45 45
Material Twisted/Bent 43 43
Device Dislodged or Dislocated 41 41
Material Perforation 34 34
Positioning Failure 34 34
Physical Resistance/Sticking 27 27
Failure to Align 25 25
Defective Device 21 21
Material Split, Cut or Torn 21 21
Retraction Problem 20 20
Output Problem 19 19
Difficult to Open or Close 17 17
Off-Label Use 16 16
Loss of or Failure to Bond 14 14
Device Contamination with Chemical or Other Material 13 13
Device Misassembled During Manufacturing /Shipping 11 11
Material Frayed 11 11
Material Fragmentation 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Vessels 3234 3234
Internal Organ Perforation 2220 2220
No Clinical Signs, Symptoms or Conditions 1905 2070
Insufficient Information 1749 1749
Anxiety 985 985
Thrombosis/Thrombus 877 877
Pain 862 862
Perforation 685 685
Abdominal Pain 580 580
Device Embedded In Tissue or Plaque 565 565
Depression 461 461
Pulmonary Embolism 436 436
Stenosis 353 353
No Information 329 329
Obstruction/Occlusion 247 247
Dyspnea 241 241
Chest Pain 201 201
Foreign Body In Patient 181 181
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 171 171
Coagulation Disorder 147 147
Occlusion 128 128
No Consequences Or Impact To Patient 126 126
Discomfort 112 112
Hemorrhage/Bleeding 111 111
Swelling/ Edema 104 104
Great Vessel Perforation 98 98
Numbness 90 90
Unspecified Tissue Injury 85 84
Ambulation Difficulties 65 65
Distress 65 65
Emotional Changes 57 57
Failure of Implant 46 46
Cardiac Perforation 41 41
Unspecified Mental, Emotional or Behavioural Problem 40 40
Embolism/Embolus 38 38
Bowel Perforation 38 38
Fatigue 34 34
Cognitive Changes 33 33
Peripheral Edema 30 30
Sleep Dysfunction 27 27
Foreign Body Embolism 27 27
Loss of Vision 24 24
Hematoma 23 23
Cramp(s) /Muscle Spasm(s) 22 22
Dizziness 21 21
Nausea 20 20
Injury 16 16
Headache 16 16
Stroke/CVA 15 15
Low Blood Pressure/ Hypotension 15 15

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc II Nov-24-2025
2 Argon Medical Devices, Inc II Jul-27-2023
3 Cook Medical Incorporated III Apr-06-2022
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