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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 7

MDR Year MDR Reports MDR Events
2018 546 546
2019 716 716
2020 802 802
2021 840 840
2022 831 831
2023 123 123

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 818 818
Activation Failure 526 526
Material Deformation 383 383
Material Separation 371 371
Difficult to Remove 338 338
Break 308 308
Fracture 304 304
Activation, Positioning or Separation Problem 247 247
Premature Activation 240 240
Improper or Incorrect Procedure or Method 213 213
Difficult or Delayed Activation 201 201
Stretched 185 185
Detachment of Device or Device Component 147 147
Mechanical Jam 144 144
Positioning Failure 140 140
Difficult to Advance 138 138
Entrapment of Device 110 110
Failure to Advance 110 110
Physical Resistance/Sticking 108 108
Obstruction of Flow 93 93
Malposition of Device 86 86
Difficult or Delayed Positioning 81 81
Misfire 79 79
Material Twisted/Bent 76 76
Migration 74 74
Positioning Problem 68 68
Patient-Device Incompatibility 59 59
Defective Device 56 56
Detachment Of Device Component 39 39
Device Dislodged or Dislocated 37 37
Insufficient Information 37 37
Complete Blockage 35 35
Device Damaged by Another Device 33 33
Deformation Due to Compressive Stress 28 28
Off-Label Use 24 24
Activation Problem 24 24
Separation Failure 20 20
Occlusion Within Device 20 20
Device-Device Incompatibility 19 19
Tear, Rip or Hole in Device Packaging 16 16
Difficult to Insert 16 16
Use of Device Problem 14 14
Product Quality Problem 13 13
Failure to Eject 13 13
Material Split, Cut or Torn 12 12
Material Integrity Problem 11 11
Patient Device Interaction Problem 11 11
Migration or Expulsion of Device 11 11
Leak/Splash 10 10
Partial Blockage 9 9
Loss of or Failure to Bond 9 9
Material Fragmentation 9 9
Device Operates Differently Than Expected 9 9
No Apparent Adverse Event 8 8
Noise, Audible 8 8
Difficult or Delayed Separation 8 8
Mechanical Problem 8 8
Inadequacy of Device Shape and/or Size 7 7
Premature Separation 7 7
Device Markings/Labelling Problem 7 7
Device Stenosis 6 6
Difficult To Position 6 6
Self-Activation or Keying 6 6
Difficult to Flush 6 6
Unintended System Motion 5 5
Device Contamination with Chemical or Other Material 5 5
Device Contaminated During Manufacture or Shipping 5 5
Material Torqued 5 5
Packaging Problem 4 4
Appropriate Term/Code Not Available 4 4
Material Invagination 4 4
Kinked 4 4
Contamination 4 4
Inaccurate Delivery 4 4
Expiration Date Error 4 4
Physical Resistance 4 4
Contamination /Decontamination Problem 4 4
Retraction Problem 4 4
Defective Component 3 3
Microbial Contamination of Device 3 3
Component Missing 3 3
Collapse 3 3
Fluid/Blood Leak 3 3
Unintended Movement 3 3
Failure to Fire 3 3
Separation Problem 3 3
Firing Problem 2 2
Component Misassembled 2 2
Human-Device Interface Problem 2 2
Material Protrusion/Extrusion 2 2
Device Handling Problem 2 2
Unsealed Device Packaging 2 2
Crack 2 2
Bent 2 2
Device Expiration Issue 2 2
Failure to Deliver 2 2
Failure to Unfold or Unwrap 2 2
Structural Problem 1 1
Inadequate or Insufficient Training 1 1
Device Inoperable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1120 1120
No Consequences Or Impact To Patient 1093 1093
Restenosis 185 185
Reocclusion 183 183
Claudication 163 163
Obstruction/Occlusion 159 159
Stenosis 153 153
Occlusion 138 138
Pain 128 128
Foreign Body In Patient 119 119
Thrombosis/Thrombus 109 109
Insufficient Information 96 96
Thrombosis 79 79
No Known Impact Or Consequence To Patient 77 77
No Patient Involvement 75 75
Device Embedded In Tissue or Plaque 69 69
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 57 57
Ischemia 54 54
Patient Problem/Medical Problem 47 47
Death 43 43
Injury 41 41
No Code Available 33 33
Vascular Dissection 31 31
Unspecified Infection 31 31
Hemorrhage/Bleeding 28 28
Aneurysm 25 25
Perforation 25 25
Embolism 23 23
Pseudoaneurysm 22 22
Unspecified Tissue Injury 21 21
Vessel Or Plaque, Device Embedded In 19 19
Hematoma 18 18
Thrombus 17 17
Stroke/CVA 15 15
Embolism/Embolus 14 14
Perforation of Vessels 13 13
Failure of Implant 12 12
Intimal Dissection 10 10
Myocardial Infarction 9 9
Numbness 9 9
No Information 9 9
Renal Failure 8 8
Tissue Breakdown 7 7
Arteriosclerosis/ Atherosclerosis 7 7
Unspecified Vascular Problem 7 7
Diminished Pulse Pressure 6 6
Rupture 6 6
Sepsis 6 6
Tissue Damage 6 6
Bacterial Infection 6 6
Calcium Deposits/Calcification 6 6
Fistula 6 6
Atrial Fibrillation 5 5
Swelling 5 5
Vasoconstriction 5 5
Swelling/ Edema 5 5
Cardiogenic Shock 4 4
Abscess 4 4
Fever 4 4
Inflammation 3 3
Hypersensitivity/Allergic reaction 3 3
High Blood Pressure/ Hypertension 3 3
Low Blood Pressure/ Hypotension 3 3
Chest Pain 3 3
Angina 3 3
Skin Erosion 3 3
Transient Ischemic Attack 3 3
Pneumonia 3 3
Reaction 3 3
Post Operative Wound Infection 3 3
Ruptured Aneurysm 3 3
Vascular System (Circulation), Impaired 2 2
Aortic Dissection 2 2
Rash 2 2
Paralysis 2 2
Nausea 2 2
Neuropathy 2 2
Respiratory Distress 2 2
Shock 2 2
Arrhythmia 2 2
Cardiac Arrest 2 2
Cellulitis 2 2
Hypovolemic Shock 2 2
Hypoxia 1 1
Infiltration into Tissue 1 1
Intracranial Hemorrhage 1 1
Bone Fracture(s) 1 1
Headache 1 1
Hearing Loss 1 1
Pulmonary Embolism 1 1
Congestive Heart Failure 1 1
Erythema 1 1
Exsanguination 1 1
Extravasation 1 1
Weakness 1 1
Heart Failure 1 1
Seroma 1 1
Urinary Tract Infection 1 1
Keratitis 1 1
Laceration(s) 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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