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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)
2018 2019 2020 2021 2022 2023
56 46 33 26 26 23

MDR Year MDR Reports MDR Events
2018 546 546
2019 716 716
2020 802 802
2021 837 837
2022 831 831
2023 593 593

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 926 926
Activation Failure 590 590
Material Deformation 421 421
Material Separation 409 409
Difficult to Remove 363 363
Break 353 353
Fracture 336 336
Activation, Positioning or Separation Problem 284 284
Premature Activation 262 262
Improper or Incorrect Procedure or Method 229 229
Difficult or Delayed Activation 228 228
Stretched 204 204
Detachment of Device or Device Component 183 183
Mechanical Jam 164 164
Positioning Failure 157 157
Difficult to Advance 155 155
Failure to Advance 136 136
Physical Resistance/Sticking 125 125
Entrapment of Device 115 115
Malposition of Device 99 99
Obstruction of Flow 98 98
Misfire 86 86
Migration 86 86
Difficult or Delayed Positioning 85 85
Material Twisted/Bent 83 83
Positioning Problem 76 76
Patient-Device Incompatibility 63 63
Defective Device 62 62
Complete Blockage 48 48
Device Dislodged or Dislocated 43 43
Insufficient Information 39 39
Detachment Of Device Component 39 39
Device Damaged by Another Device 37 37
Deformation Due to Compressive Stress 36 36
Off-Label Use 27 27
Device-Device Incompatibility 24 24
Activation Problem 24 24
Separation Failure 21 21
Difficult to Insert 20 20
Occlusion Within Device 20 20
Tear, Rip or Hole in Device Packaging 17 17
Use of Device Problem 16 16
Device Stenosis 16 16
Material Split, Cut or Torn 14 14
Migration or Expulsion of Device 14 14
Product Quality Problem 13 13
Failure to Eject 13 13
Partial Blockage 12 12
Loss of or Failure to Bond 12 12
Patient Device Interaction Problem 11 11
Material Integrity Problem 11 11
No Apparent Adverse Event 11 11
Difficult or Delayed Separation 10 10
Leak/Splash 10 10
Material Fragmentation 9 9
Noise, Audible 9 9
Device Operates Differently Than Expected 9 9
Separation Problem 8 8
Mechanical Problem 8 8
Difficult to Flush 7 7
Inadequacy of Device Shape and/or Size 7 7
Premature Separation 7 7
Device Markings/Labelling Problem 7 7
Appropriate Term/Code Not Available 6 6
Self-Activation or Keying 6 6
Difficult To Position 6 6
Unintended System Motion 5 5
Material Invagination 5 5
Contamination 5 5
Material Torqued 5 5
Device Contaminated During Manufacture or Shipping 5 5
Device Contamination with Chemical or Other Material 5 5
Unintended Movement 4 4
Packaging Problem 4 4
Contamination /Decontamination Problem 4 4
Kinked 4 4
Fluid/Blood Leak 4 4
Retraction Problem 4 4
Inaccurate Delivery 4 4
Defective Component 4 4
Microbial Contamination of Device 4 4
Physical Resistance 4 4
Expiration Date Error 4 4
Component Missing 3 3
Crack 3 3
Collapse 3 3
Failure to Fire 3 3
Human-Device Interface Problem 3 3
Device Handling Problem 3 3
Firing Problem 2 2
Component Misassembled 2 2
Poor Visibility 2 2
Material Protrusion/Extrusion 2 2
Accessory Incompatible 2 2
Bent 2 2
Material Frayed 2 2
Device Expiration Issue 2 2
Unsealed Device Packaging 2 2
Poor Quality Image 2 2
Failure to Deliver 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1399 1399
No Consequences Or Impact To Patient 1093 1093
Restenosis 247 247
Obstruction/Occlusion 210 210
Pain 184 184
Reocclusion 183 183
Claudication 163 163
Stenosis 162 162
Occlusion 138 138
Foreign Body In Patient 131 131
Thrombosis/Thrombus 129 129
Insufficient Information 106 106
Thrombosis 79 79
No Known Impact Or Consequence To Patient 77 77
No Patient Involvement 75 75
Device Embedded In Tissue or Plaque 72 72
Ischemia 67 67
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 65 65
Patient Problem/Medical Problem 47 47
Death 43 43
Injury 41 41
Vascular Dissection 38 38
Unspecified Infection 34 34
No Code Available 33 33
Hemorrhage/Bleeding 32 32
Pseudoaneurysm 29 29
Aneurysm 28 28
Perforation 26 26
Unspecified Tissue Injury 25 25
Embolism 23 23
Hematoma 23 23
Vessel Or Plaque, Device Embedded In 19 19
Embolism/Embolus 18 18
Thrombus 17 17
Perforation of Vessels 17 17
Stroke/CVA 16 16
Failure of Implant 12 12
Myocardial Infarction 12 12
Renal Failure 10 10
Intimal Dissection 10 10
No Information 9 9
Numbness 9 9
Discomfort 8 8
Arteriosclerosis/ Atherosclerosis 8 8
Bacterial Infection 8 8
Unspecified Vascular Problem 7 7
Tissue Breakdown 7 7
Diminished Pulse Pressure 6 6
Rupture 6 6
Calcium Deposits/Calcification 6 6
Atrial Fibrillation 6 6
Fistula 6 6
Sepsis 6 6
Tissue Damage 6 6
Swelling 5 5
Vasoconstriction 5 5
Ruptured Aneurysm 5 5
Swelling/ Edema 5 5
Cardiogenic Shock 4 4
Skin Discoloration 4 4
Fever 4 4
Hypersensitivity/Allergic reaction 4 4
Low Blood Pressure/ Hypotension 4 4
Abscess 4 4
Chest Pain 3 3
Angina 3 3
High Blood Pressure/ Hypertension 3 3
Skin Erosion 3 3
Transient Ischemic Attack 3 3
Inflammation 3 3
Pneumonia 3 3
Reaction 3 3
Post Operative Wound Infection 3 3
Respiratory Failure 3 3
Ischemia Stroke 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Localized Skin Lesion 2 2
Vascular System (Circulation), Impaired 2 2
Aortic Dissection 2 2
Impaired Healing 2 2
Rash 2 2
Paralysis 2 2
Neuropathy 2 2
Nausea 2 2
Necrosis 2 2
Shock 2 2
Respiratory Distress 2 2
Hypovolemic Shock 2 2
Extravasation 2 2
Arrhythmia 2 2
Cardiac Arrest 2 2
Cellulitis 2 2
Pulmonary Embolism 1 1
Congestive Heart Failure 1 1
Endocarditis 1 1
Erythema 1 1
Exsanguination 1 1
Intracranial Hemorrhage 1 1
Bone Fracture(s) 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Feb-22-2018
2 Cardinal Health Inc. II Dec-20-2019
3 Medtronic Inc. II Aug-26-2022
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