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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 205 205

Device Problems MDRs with this Device Problem Events in those MDRs
Structural Problem 3575 3575
Device Tipped Over 1734 1734
Appropriate Device Problem Term/Code Not Available 1395 1395
Unintended Movement 1236 1235
Detachment of Device or Device Component 1050 1055
Difficult to Remove 995 1002
Obstruction of Flow 893 893
Patient-Device Incompatibility 863 962
Malposition of Device 668 718
Fracture 372 372
Migration 325 327
Adverse Event Without Identified Device or Use Problem 292 292
Activation Failure 292 292
Patient Device Interaction Problem 286 337
Inadequate Filtration Process 221 221
Insufficient Device Problem Information 197 197
Positioning Problem 161 163
Failure to Advance 156 156
Material Deformation 156 158
Migration or Expulsion of Device 139 141
Improper or Incorrect Procedure or Method 102 102
Difficult or Delayed Activation 67 67
Break 61 61
Deformation Due to Compressive Stress 54 54
Material Puncture/Hole 52 52
Activation Problem 51 51
Failure to Unfold or Unwrap 49 49
Activation, Positioning or Separation Problem 47 47
Difficult to Advance 47 47
Difficult to Insert 47 47
Premature Activation 47 47
Device Dislodged or Dislocated 41 41
Material Twisted/Bent 40 40
Positioning Failure 31 31
Failure to Align 25 25
Material Split, Cut or Torn 21 21
Retraction Problem 20 20
Physical Resistance/Sticking 20 20
Off-Label Use 16 16
Loss of or Failure to Bond 14 14
Device Contamination with Chemical or Other Material 13 13
Material Frayed 11 11
Device Misassembled During Manufacturing /Shipping 11 11
Misassembled 7 7
Difficult to Fold, Unfold or Collapse 7 7
Entrapment of Device 7 7
Device-Device Incompatibility 7 7
Therapy Delivered to Incorrect Body Area 6 6
Connection Problem 6 6
Tear, Rip or Hole in Device Packaging 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Vessels 3240 3240
Internal Organ Perforation 2222 2222
No Clinical Signs, Symptoms or Conditions 1944 2109
Insufficient Information 1754 1754
Anxiety 985 985
Thrombosis/Thrombus 877 877
Pain 862 862
Perforation 686 686
Abdominal Pain 580 580
Device Embedded In Tissue or Plaque 568 568
Depression 461 461
Pulmonary Embolism 436 436
Stenosis 353 353
No Information 329 329
Obstruction/Occlusion 247 247
Dyspnea 242 242
Chest Pain 202 202
Foreign Body In Patient 190 190
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 174 174
Coagulation Disorder 147 147
Occlusion 128 128
No Consequences Or Impact To Patient 126 126
Discomfort 112 112
Hemorrhage/Blood Loss/Bleeding 111 111
Swelling/ Edema 104 104
Great Vessel Perforation 100 100
Numbness 90 90
Unspecified Tissue Injury 86 85
Distress 65 65
Ambulation or Postural Difficulties 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 39 39
Bowel Perforation 38 38
Fatigue 34 34
Cognitive Changes 33 33
Peripheral Edema 30 30
Foreign Body Embolism 30 30
Sleep Dysfunction 27 27
Loss of Vision 24 24
Hematoma 23 23
Cramp(s) /Muscle Spasm(s) 22 22
Dizziness 21 21
Nausea 20 20
Headache 16 16
Injury 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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