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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stent, superficial femoral artery
Definition Stent, Superficial Femoral Artery -- a metal scaffold placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen
Product CodeNIP
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
46 33 26 26 27 11

MDR Year MDR Reports MDR Events
2019 716 716
2020 802 802
2021 837 837
2022 831 831
2023 879 879
2024 309 309

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 968 968
Activation Failure 662 662
Material Separation 443 443
Material Deformation 427 427
Break 380 380
Difficult to Remove 346 346
Fracture 336 336
Activation, Positioning or Separation Problem 284 284
Premature Activation 276 276
Difficult or Delayed Activation 233 233
Improper or Incorrect Procedure or Method 226 226
Stretched 216 216
Detachment of Device or Device Component 207 207
Mechanical Jam 190 190
Difficult to Advance 169 169
Failure to Advance 138 138
Physical Resistance/Sticking 136 136
Positioning Failure 117 117
Malposition of Device 105 105
Obstruction of Flow 93 93
Migration 91 91
Entrapment of Device 85 85
Material Twisted/Bent 84 84
Misfire 72 72
Patient-Device Incompatibility 71 71
Positioning Problem 71 71
Defective Device 69 69
Difficult or Delayed Positioning 59 59
Complete Blockage 57 57
Device Dislodged or Dislocated 52 52
Insufficient Information 48 48
Deformation Due to Compressive Stress 37 37
Device Damaged by Another Device 36 36
Off-Label Use 31 31
Activation Problem 28 28
Device Stenosis 25 25
Device-Device Incompatibility 23 23
Separation Failure 21 21
Use of Device Problem 21 21
Difficult to Insert 21 21
Tear, Rip or Hole in Device Packaging 19 19
Partial Blockage 18 18
Material Split, Cut or Torn 15 15
Noise, Audible 14 14
Device Markings/Labelling Problem 14 14
Failure to Eject 13 13
Material Integrity Problem 12 12
Product Quality Problem 12 12
Loss of or Failure to Bond 12 12
Material Fragmentation 12 12
Patient Device Interaction Problem 11 11
No Apparent Adverse Event 11 11
Difficult or Delayed Separation 10 10
Contamination 10 10
Leak/Splash 10 10
Migration or Expulsion of Device 10 10
Separation Problem 9 9
Premature Separation 7 7
Appropriate Term/Code Not Available 7 7
Difficult to Flush 7 7
Self-Activation or Keying 7 7
Microbial Contamination of Device 7 7
Material Invagination 6 6
Packaging Problem 6 6
Device Contaminated During Manufacture or Shipping 5 5
Mechanical Problem 5 5
Retraction Problem 5 5
Fluid/Blood Leak 5 5
Inadequacy of Device Shape and/or Size 5 5
Expiration Date Error 4 4
Collapse 4 4
Unintended System Motion 4 4
Device Contamination with Chemical or Other Material 4 4
Unintended Movement 4 4
Device Handling Problem 3 3
Human-Device Interface Problem 3 3
Crack 3 3
Material Frayed 3 3
Contamination /Decontamination Problem 3 3
Component Missing 3 3
Defective Component 3 3
Failure to Deliver 2 2
Failure to Fire 2 2
Accessory Incompatible 2 2
Unsealed Device Packaging 2 2
Peeled/Delaminated 2 2
Poor Quality Image 2 2
Compatibility Problem 2 2
Material Protrusion/Extrusion 2 2
Component Misassembled 2 2
Poor Visibility 2 2
Wrong Label 1 1
Inaccurate Information 1 1
Expulsion 1 1
Difficult to Open or Close 1 1
No Flow 1 1
Therapeutic or Diagnostic Output Failure 1 1
Delivered as Unsterile Product 1 1
Loose or Intermittent Connection 1 1
Labelling, Instructions for Use or Training Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1770 1770
No Consequences Or Impact To Patient 761 761
Restenosis 300 300
Obstruction/Occlusion 267 267
Pain 215 215
Reocclusion 166 166
Thrombosis/Thrombus 154 154
Stenosis 153 153
Foreign Body In Patient 149 149
Claudication 148 148
Insufficient Information 120 120
Occlusion 105 105
Device Embedded In Tissue or Plaque 80 80
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 72 72
Ischemia 68 68
Thrombosis 63 63
No Patient Involvement 57 57
Vascular Dissection 50 50
No Known Impact Or Consequence To Patient 48 48
Unspecified Infection 42 42
Injury 39 39
Hemorrhage/Bleeding 32 32
Death 31 31
Patient Problem/Medical Problem 30 30
Pseudoaneurysm 30 30
No Code Available 29 29
Aneurysm 28 28
Unspecified Tissue Injury 26 26
Hematoma 24 24
Perforation of Vessels 24 24
Perforation 24 24
Embolism/Embolus 23 23
Stroke/CVA 18 18
Embolism 16 16
Failure of Implant 14 14
Myocardial Infarction 14 14
Unspecified Vascular Problem 14 14
Vessel Or Plaque, Device Embedded In 13 13
Thrombus 11 11
Renal Failure 10 10
Bacterial Infection 10 10
Swelling/ Edema 10 10
Tissue Breakdown 9 9
Numbness 9 9
Intimal Dissection 9 9
Sepsis 8 8
Discomfort 8 8
Arteriosclerosis/ Atherosclerosis 8 8
Cramp(s) /Muscle Spasm(s) 7 7
Rupture 7 7
Skin Discoloration 6 6
Calcium Deposits/Calcification 6 6
Atrial Fibrillation 6 6
Fistula 6 6
No Information 6 6
Ruptured Aneurysm 5 5
Impaired Healing 5 5
Fever 5 5
Hypersensitivity/Allergic reaction 5 5
Tissue Damage 5 5
Transient Ischemic Attack 4 4
Vasoconstriction 4 4
Low Blood Pressure/ Hypotension 4 4
Abscess 4 4
Angina 4 4
Swelling 4 4
Ischemia Stroke 3 3
Post Operative Wound Infection 3 3
Diminished Pulse Pressure 3 3
Respiratory Failure 3 3
Localized Skin Lesion 3 3
Arrhythmia 3 3
Cardiac Arrest 3 3
Skin Erosion 3 3
Cardiogenic Shock 3 3
Pneumonia 3 3
Nausea 3 3
Necrosis 3 3
Inflammation 3 3
Neuropathy 2 2
Paralysis 2 2
Respiratory Distress 2 2
Ulcer 2 2
Rash 2 2
Shock 2 2
Cellulitis 2 2
Pulmonary Embolism 2 2
Chest Pain 2 2
Hypovolemic Shock 2 2
High Blood Pressure/ Hypertension 2 2
Extravasation 2 2
Skin Infection 2 2
Renal Impairment 2 2
Aortic Dissection 2 2
Thrombocytopenia 2 2
Foreign Body Embolism 2 2
Unspecified Blood or Lymphatic problem 1 1
Unspecified Immune System Problem 1 1
Test Result 1 1
Cerebral Hyperperfusion Syndrome 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health Inc. II Dec-20-2019
2 Medtronic Inc. II Jan-02-2024
3 Medtronic Inc. II Aug-26-2022
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