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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
2020 5405 5405
2021 5357 5516
2022 2191 2196
2023 583 583
2024 406 406
2025 438 438
2026 180 180

Device Problems MDRs with this Device Problem Events in those MDRs
Structural Problem 4494 4494
Device Tipped Over 2306 2306
Unintended Movement 1827 1826
Difficult to Remove 1816 1823
Appropriate Term/Code Not Available 1752 1752
Detachment of Device or Device Component 1487 1492
Insufficient Information 1434 1434
Malposition of Device 1397 1447
Obstruction of Flow 1148 1148
Patient-Device Incompatibility 1085 1184
Patient Device Interaction Problem 1077 1128
Adverse Event Without Identified Device or Use Problem 966 966
Fracture 805 805
Migration 716 718
Positioning Problem 559 561
Migration or Expulsion of Device 543 545
Activation Failure 362 362
Inadequate Filtration Process 308 308
Failure to Align 285 285
Material Deformation 243 245
Failure to Advance 182 182
Entrapment of Device 130 130
Break 126 126
Improper or Incorrect Procedure or Method 118 118
Therapeutic or Diagnostic Output Failure 103 103
Difficult or Delayed Activation 100 100
Activation, Positioning or Separation Problem 81 81
Activation Problem 69 69
Material Puncture/Hole 65 65
Difficult to Advance 64 64
Material Perforation 60 60
Deformation Due to Compressive Stress 58 58
Material Twisted/Bent 57 57
Premature Activation 56 56
Difficult to Insert 54 54
Device Dislodged or Dislocated 51 51
Failure to Unfold or Unwrap 50 50
Positioning Failure 40 40
Physical Resistance/Sticking 38 38
Defective Device 36 36
Material Split, Cut or Torn 24 24
Retraction Problem 23 23
Difficult to Open or Close 22 22
Output Problem 19 19
Off-Label Use 16 16
Loss of or Failure to Bond 14 14
Device Contamination with Chemical or Other Material 14 14
Material Fragmentation 12 12
Difficult or Delayed Separation 11 11
Device Misassembled During Manufacturing /Shipping 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Vessels 4837 4837
Internal Organ Perforation 2932 2932
No Clinical Signs, Symptoms or Conditions 2225 2390
Insufficient Information 1781 1781
Perforation 1595 1595
No Information 1572 1572
Pain 1345 1345
Anxiety 1268 1268
Abdominal Pain 954 954
Thrombosis/Thrombus 933 933
No Consequences Or Impact To Patient 925 925
Pulmonary Embolism 847 848
Device Embedded In Tissue or Plaque 683 683
Depression 562 562
Stenosis 500 500
Thrombosis 410 410
Vessel Or Plaque, Device Embedded In 380 380
Dyspnea 351 351
Chest Pain 329 329
Coagulation Disorder 326 326
Occlusion 323 323
Obstruction/Occlusion 312 312
Great Vessel Perforation 245 245
Foreign Body In Patient 230 230
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 186 186
Thrombus 151 151
No Known Impact Or Consequence To Patient 140 140
Hemorrhage/Bleeding 132 132
Injury 131 131
Discomfort 125 125
Death 113 113
Failure of Implant 113 113
Numbness 112 112
Swelling/ Edema 110 110
Distress 98 98
Unspecified Tissue Injury 85 84
Ambulation Difficulties 79 79
Emotional Changes 70 70
Cardiac Perforation 69 69
No Code Available 60 60
Bowel Perforation 56 56
Swelling 53 53
Unspecified Mental, Emotional or Behavioural Problem 47 47
Fatigue 43 43
Embolism/Embolus 40 40
Cognitive Changes 37 37
Hematoma 35 35
Thromboembolism 33 33
Foreign Body Embolism 32 32
Peripheral Edema 31 31

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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