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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
21 19 17 16 21 42 40 50 34 56 46 33 26 26 27 10

MDR Year MDR Reports MDR Events
2014 403 403
2015 600 600
2016 846 846
2017 789 789
2018 546 546
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 1430 1430
Fracture 708 708
Activation Failure 701 701
Activation, Positioning or Separation Problem 669 669
Material Deformation 666 666
Difficult to Remove 645 645
Break 612 612
Positioning Failure 581 581
Material Separation 481 481
Premature Activation 405 405
Improper or Incorrect Procedure or Method 363 363
Detachment Of Device Component 341 341
Stretched 314 314
Difficult or Delayed Positioning 281 281
Detachment of Device or Device Component 254 254
Difficult or Delayed Activation 251 251
Occlusion Within Device 232 232
Failure to Advance 223 223
Mechanical Jam 211 211
Difficult to Advance 204 204
Entrapment of Device 187 187
Material Twisted/Bent 162 162
Physical Resistance/Sticking 144 144
Malposition of Device 132 132
Obstruction of Flow 124 124
Insufficient Information 110 110
Device Operates Differently Than Expected 102 102
Misfire 98 98
Migration 98 98
Positioning Problem 98 98
Bent 92 92
Device Dislodged or Dislocated 80 80
Patient-Device Incompatibility 78 78
Defective Device 75 75
Material Torqued 62 62
Complete Blockage 62 62
Migration or Expulsion of Device 62 62
Leak/Splash 61 61
Device Damaged by Another Device 53 53
Partial Blockage 41 41
Difficult To Position 40 40
Deformation Due to Compressive Stress 39 39
Sticking 37 37
Off-Label Use 32 32
Kinked 31 31
Retraction Problem 30 30
Physical Resistance 30 30
Difficult to Insert 29 29
Activation Problem 28 28
Device-Device Incompatibility 27 27
Inaccurate Delivery 26 26
Use of Device Problem 26 26
Device Stenosis 25 25
Separation Failure 24 24
Tear, Rip or Hole in Device Packaging 22 22
Device Markings/Labelling Problem 19 19
Device Expiration Issue 18 18
Loss of or Failure to Bond 17 17
Torn Material 17 17
Material Split, Cut or Torn 16 16
Mechanical Problem 16 16
Noise, Audible 15 15
No Apparent Adverse Event 15 15
Material Integrity Problem 14 14
Appropriate Term/Code Not Available 13 13
Failure to Eject 13 13
Component Missing 13 13
Product Quality Problem 13 13
Material Fragmentation 13 13
Contamination 12 12
Inadequacy of Device Shape and/or Size 11 11
Patient Device Interaction Problem 11 11
Self-Activation or Keying 10 10
Difficult or Delayed Separation 10 10
Separation Problem 9 9
Device Contamination with Chemical or Other Material 9 9
Packaging Problem 8 8
Delivered as Unsterile Product 8 8
Fluid/Blood Leak 8 8
Difficult to Flush 8 8
Microbial Contamination of Device 7 7
Premature Separation 7 7
Material Invagination 6 6
Device Difficult to Setup or Prepare 6 6
Defective Component 6 6
Device Damaged Prior to Use 5 5
Unintended System Motion 5 5
Material Rupture 5 5
Collapse 5 5
Device Contaminated During Manufacture or Shipping 5 5
Compatibility Problem 4 4
Material Protrusion/Extrusion 4 4
Unintended Movement 4 4
Device Handling Problem 4 4
Dent in Material 4 4
Expiration Date Error 4 4
Contamination /Decontamination Problem 4 4
Unsealed Device Packaging 4 4
Peeled/Delaminated 4 4
Unintended Collision 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2367 2367
No Clinical Signs, Symptoms or Conditions 1772 1772
Stenosis 410 410
No Known Impact Or Consequence To Patient 356 356
Pain 354 354
Occlusion 329 330
Reocclusion 310 310
Restenosis 300 300
Obstruction/Occlusion 274 274
Claudication 250 250
Foreign Body In Patient 228 228
Thrombosis 222 223
Thrombosis/Thrombus 158 158
No Patient Involvement 148 148
Device Embedded In Tissue or Plaque 142 142
Insufficient Information 120 120
Death 106 106
Ischemia 105 105
Hemorrhage/Bleeding 98 98
No Code Available 82 82
Patient Problem/Medical Problem 73 73
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 72 72
Unspecified Infection 68 68
Vascular System (Circulation), Impaired 64 64
No Information 64 64
Vascular Dissection 63 63
Thrombus 62 62
Injury 60 60
Pseudoaneurysm 44 44
Aneurysm 38 38
Hematoma 36 36
Vessel Or Plaque, Device Embedded In 35 35
Embolism 34 34
Perforation 34 34
Perforation of Vessels 29 29
Unspecified Tissue Injury 26 26
Embolism/Embolus 23 23
Rupture 23 23
Stroke/CVA 22 22
Intimal Dissection 19 19
Diminished Pulse Pressure 19 19
Myocardial Infarction 17 18
Failure of Implant 15 15
Calcium Deposits/Calcification 15 15
Fistula 15 15
Tissue Damage 15 15
Renal Failure 15 15
Low Blood Pressure/ Hypotension 14 15
Pneumonia 14 14
Unspecified Vascular Problem 14 14
Bacterial Infection 13 13
Respiratory Distress 13 13
Numbness 13 13
Sepsis 12 12
Hypersensitivity/Allergic reaction 11 11
Discomfort 10 10
Swelling/ Edema 10 10
Paraplegia 9 9
Tissue Breakdown 9 9
Septic Shock 9 9
Swelling 9 9
Vasoconstriction 9 9
Fever 9 9
Cardiac Arrest 8 8
Test Result 8 8
Impaired Healing 8 8
Arteriosclerosis/ Atherosclerosis 8 8
Cramp(s) /Muscle Spasm(s) 7 7
Blood Loss 7 7
Skin Discoloration 7 7
Atrial Fibrillation 7 7
Abdominal Pain 7 7
Extravasation 6 6
Abscess 5 5
Laceration(s) 5 5
Necrosis 5 5
Cardiogenic Shock 5 5
Respiratory Failure 5 5
Ruptured Aneurysm 5 5
Weakness 4 4
Transient Ischemic Attack 4 4
Hemothorax 4 4
Inflammation 4 4
Angina 4 4
Arrhythmia 3 3
Anemia 3 3
Fall 3 3
Erythema 3 3
Chest Pain 3 3
Hypovolemic Shock 3 3
High Blood Pressure/ Hypertension 3 3
Headache 3 3
Neurological Deficit/Dysfunction 3 3
Nausea 3 3
Skin Erosion 3 3
Rash 3 3
Post Operative Wound Infection 3 3
Reaction 3 3
Ischemia Stroke 3 3
Localized Skin Lesion 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc I Oct-10-2013
2 Boston Scientific Corporation II Feb-22-2018
3 Boston Scientific Corporation I Jun-16-2011
4 Cardinal Health Inc. II Dec-20-2019
5 Cordis Corporation II Jun-06-2013
6 Ev3, Inc. II Jun-23-2016
7 Medtronic Inc. II Jan-02-2024
8 Medtronic Inc. II Aug-26-2022
9 Medtronic Inc. II Nov-29-2017
10 Terumo Medical Corp II Nov-29-2016
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