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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 8

MDR Year MDR Reports MDR Events
2019 716 716
2020 802 802
2021 837 837
2022 831 831
2023 879 879
2024 218 218

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 946 946
Activation Failure 649 649
Material Separation 427 427
Material Deformation 423 423
Break 369 369
Difficult to Remove 334 334
Fracture 332 332
Activation, Positioning or Separation Problem 277 277
Premature Activation 265 265
Difficult or Delayed Activation 229 229
Improper or Incorrect Procedure or Method 218 218
Stretched 213 213
Detachment of Device or Device Component 197 197
Mechanical Jam 186 186
Difficult to Advance 165 165
Failure to Advance 135 135
Physical Resistance/Sticking 131 131
Positioning Failure 114 114
Malposition of Device 104 104
Obstruction of Flow 93 93
Migration 90 90
Material Twisted/Bent 84 84
Entrapment of Device 83 83
Misfire 71 71
Positioning Problem 71 71
Defective Device 69 69
Patient-Device Incompatibility 69 69
Difficult or Delayed Positioning 57 57
Complete Blockage 55 55
Device Dislodged or Dislocated 51 51
Insufficient Information 47 47
Deformation Due to Compressive Stress 36 36
Device Damaged by Another Device 36 36
Off-Label Use 31 31
Activation Problem 26 26
Device Stenosis 25 25
Device-Device Incompatibility 23 23
Separation Failure 21 21
Difficult to Insert 21 21
Use of Device Problem 20 20
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
Material Fragmentation 12 12
Loss of or Failure to Bond 11 11
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
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
Retraction 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
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
Peeled/Delaminated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1712 1712
No Consequences Or Impact To Patient 761 761
Restenosis 290 290
Obstruction/Occlusion 261 261
Pain 208 208
Reocclusion 166 166
Stenosis 152 152
Thrombosis/Thrombus 150 150
Claudication 148 148
Foreign Body In Patient 141 141
Insufficient Information 120 120
Occlusion 105 105
Device Embedded In Tissue or Plaque 78 78
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 72 72
Ischemia 65 65
Thrombosis 63 63
No Patient Involvement 57 57
No Known Impact Or Consequence To Patient 48 48
Vascular Dissection 48 48
Unspecified Infection 42 42
Injury 39 39
Hemorrhage/Bleeding 31 31
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 20 20
Stroke/CVA 18 18
Embolism 16 16
Myocardial Infarction 14 14
Unspecified Vascular Problem 14 14
Vessel Or Plaque, Device Embedded In 13 13
Failure of Implant 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
Rupture 7 7
Skin Discoloration 6 6
Calcium Deposits/Calcification 6 6
Atrial Fibrillation 6 6
Fistula 6 6
No Information 6 6
Cramp(s) /Muscle Spasm(s) 6 6
Ruptured Aneurysm 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
Impaired Healing 4 4
Post Operative Wound Infection 3 3
Diminished Pulse Pressure 3 3
Respiratory Failure 3 3
Ischemia Stroke 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
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
Foreign Body Embolism 2 2
Renal Impairment 2 2
Aortic Dissection 2 2
Prolapse 1 1
Fungal Infection 1 1
Extubate 1 1
Complaint, Ill-Defined 1 1
Unspecified Blood or Lymphatic problem 1 1
Unspecified Immune System Problem 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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