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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device filter, intravascular, cardiovascular
Product CodeDTK
Regulation Number 870.3375
Device Class 2


Premarket Reviews
ManufacturerDecision
ALN IMPLANTS CHIRURGICAUX
  SUBSTANTIALLY EQUIVALENT 1
NOVATE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2017 4364 4364
2018 3938 3938
2019 6467 6474
2020 5404 5404
2021 5357 5516
2022 2074 2079

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 7764 7764
Appropriate Term/Code Not Available 5473 5473
Difficult to Remove 5356 5364
Structural Problem 4374 4374
Unintended Movement 3249 3248
Malposition of Device 3092 3144
Patient Device Interaction Problem 2321 2374
Adverse Event Without Identified Device or Use Problem 2185 2185
Device Tipped Over 2033 2033
Detachment of Device or Device Component 1991 2001
Fracture 1969 1969
Migration or Expulsion of Device 1858 1861
Failure to Align 1533 1533
Patient-Device Incompatibility 1427 1528
Obstruction of Flow 1230 1230
Migration 1059 1061
Positioning Problem 616 618
Entrapment of Device 386 386
Material Deformation 341 343
Extrusion 328 328
Activation Failure 299 299
Inadequate Filtration Process 289 289
Failure to Advance 156 156
Material Perforation 136 136
Break 133 133
Activation, Positioning or Separation Problem 133 133
Occlusion Within Device 126 126
Therapeutic or Diagnostic Output Failure 120 120
Material Twisted/Bent 89 89
Difficult or Delayed Activation 86 86
Difficult or Delayed Positioning 80 80
Positioning Failure 80 80
Material Separation 73 73
Premature Activation 73 73
Difficult to Advance 72 72
Kinked 69 69
Improper or Incorrect Procedure or Method 56 56
Material Puncture/Hole 55 55
Defective Device 51 51
Complete Blockage 41 41
Device Dislodged or Dislocated 39 39
Difficult to Insert 36 36
Retraction Problem 34 34
Defective Component 30 30
Material Fragmentation 30 30
Difficult to Open or Close 29 29
Activation Problem 29 29
Deformation Due to Compressive Stress 27 27
Physical Resistance/Sticking 26 26
Bent 23 23
Detachment Of Device Component 23 23
Output Problem 22 22
Material Frayed 16 16
Material Split, Cut or Torn 15 15
Device Operates Differently Than Expected 15 15
Partial Blockage 14 14
Material Protrusion/Extrusion 13 13
Difficult or Delayed Separation 11 11
Unexpected Therapeutic Results 11 11
Use of Device Problem 10 10
Material Erosion 10 10
Collapse 9 9
Failure to Unfold or Unwrap 9 9
Coagulation in Device or Device Ingredient 8 8
Crack 8 8
Loose or Intermittent Connection 7 7
Off-Label Use 7 7
Therapy Delivered to Incorrect Body Area 7 7
Difficult To Position 7 7
Sharp Edges 7 7
Torn Material 7 7
Filtration Problem 7 7
Device-Device Incompatibility 7 7
Split 7 7
Device Contamination with Chemical or Other Material 6 6
Device Handling Problem 6 6
Device Issue 6 6
Component Missing 5 5
No Apparent Adverse Event 5 5
Device Damaged by Another Device 4 4
Device Or Device Fragments Location Unknown 4 4
Connection Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Sticking 4 4
Mechanical Problem 4 4
Leak/Splash 4 4
Component Incompatible 4 4
Loss of or Failure to Bond 4 4
Peeled/Delaminated 3 3
Difficult to Fold, Unfold or Collapse 3 3
Tear, Rip or Hole in Device Packaging 3 3
Device Operational Issue 3 3
Material Integrity Problem 3 3
Protective Measures Problem 3 3
Premature Separation 3 3
Separation Problem 2 2
Mechanical Jam 2 2
Material Distortion 2 2
Impedance Problem 2 2
Device Markings/Labelling Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Vessels 9433 9433
No Information 7925 7925
Internal Organ Perforation 4655 4655
Pain 3282 3282
Perforation 2685 2685
No Consequences Or Impact To Patient 2484 2491
Anxiety 2315 2315
Thrombosis 2193 2193
Vessel Or Plaque, Device Embedded In 2188 2188
Pulmonary Embolism 2147 2149
No Clinical Signs, Symptoms or Conditions 1623 1795
Abdominal Pain 1573 1573
Insufficient Information 1493 1493
Occlusion 1330 1330
Device Embedded In Tissue or Plaque 908 908
No Code Available 880 880
No Known Impact Or Consequence To Patient 855 855
Thrombosis/Thrombus 848 848
Chest Pain 767 767
Stenosis 730 730
Coagulation Disorder 727 727
Thrombus 693 693
Depression 684 684
Dyspnea 681 681
Great Vessel Perforation 539 539
Death 517 518
Injury 413 413
Swelling 391 391
Obstruction/Occlusion 308 308
Foreign Body In Patient 295 295
Embolus 253 253
Hemorrhage/Bleeding 211 211
Numbness 174 174
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 158 158
Discomfort 156 156
Failure of Implant 138 138
Blood Loss 135 135
Cardiac Perforation 121 121
Emotional Changes 112 112
Distress 110 110
Hematoma 102 102
Swelling/ Edema 97 97
Ambulation Difficulties 91 91
Bowel Perforation 86 86
Vascular System (Circulation), Impaired 85 85
Unspecified Tissue Injury 85 84
Embolism 83 83
Edema 81 81
Fatigue 75 75
Disability 61 61
Nausea 58 58
Thromboembolism 56 56
Pericardial Effusion 48 48
Stroke/CVA 48 48
Scarring 46 46
Unspecified Mental, Emotional or Behavioural Problem 42 42
Dizziness 42 42
Sleep Dysfunction 41 41
Cognitive Changes 37 37
Unspecified Infection 34 34
Embolism/Embolus 33 33
Weakness 32 32
Cardiac Arrest 32 32
Headache 30 30
Myocardial Infarction 27 27
Loss of Vision 26 26
Scar Tissue 25 25
Extravasation 25 25
Sepsis 24 24
High Blood Pressure/ Hypertension 24 24
Abdominal Cramps 24 24
Calcium Deposits/Calcification 22 22
Peripheral Edema 22 22
Erosion 21 21
Low Blood Pressure/ Hypotension 21 21
Cardiac Tamponade 21 21
Cramp(s) /Muscle Spasm(s) 21 21
Hematuria 21 21
Pseudoaneurysm 21 21
Cramp(s) 20 20
Renal Failure 20 20
Tachycardia 20 20
Inflammation 19 19
Aneurysm 19 19
Patient Problem/Medical Problem 19 19
Bone Fracture(s) 18 18
Transient Ischemic Attack 17 17
Ulcer 17 17
Palpitations 16 16
Nerve Damage 16 16
Cellulitis 16 16
Muscle Weakness 15 15
Weight Changes 15 15
Vomiting 14 14
Neuropathy 14 14
Arrhythmia 13 13
Atrial Fibrillation 13 13
Chest Tightness/Pressure 13 13
Anemia 12 12
Syncope 11 11

Recalls
Manufacturer Recall Class Date Posted
1 Cook Medical Incorporated III Apr-06-2022
2 Cook Medical Incorporated III Mar-19-2019
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