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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)
2016 2017 2018 2019 2020 2021
50 34 56 46 33 9

MDR Year MDR Reports MDR Events
2016 846 846
2017 789 789
2018 546 546
2019 716 716
2020 800 800
2021 309 309

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 738 738
Activation, Positioning or SeparationProblem 424 424
Fracture 390 390
Material Deformation 351 351
Difficult to Remove 346 346
Positioning Failure 335 335
Break 280 280
Activation Failure 277 277
Material Separation 245 245
Detachment Of Device Component 216 216
Premature Activation 206 206
Improper or Incorrect Procedure or Method 202 202
Stretched 189 189
Difficult or Delayed Positioning 175 175
Occlusion Within Device 172 172
Difficult or Delayed Activation 135 135
Entrapment of Device 131 131
Detachment of Device or Device Component 96 96
Failure to Advance 95 95
Difficult to Advance 95 95
Mechanical Jam 87 87
Bent 78 78
Physical Resistance/Sticking 74 74
Material Twisted/Bent 71 71
Obstruction of Flow 61 61
Malposition of Device 57 57
Positioning Problem 56 56
Device Operates Differently Than Expected 56 56
Misfire 55 55
Migration 45 45
Insufficient Information 45 45
Patient-Device Incompatibility 43 43
Defective Device 39 39
Material Torqued 38 38
Device Dislodged or Dislocated 32 32
Device Damaged by Another Device 28 28
Migration or Expulsion of Device 28 28
Kinked 24 24
Difficult To Position 23 23
Retraction Problem 20 20
Deformation Due to Compressive Stress 19 19
Inaccurate Delivery 18 18
Physical Resistance 17 17
Tear, Rip or Hole in Device Packaging 17 17
Sticking 17 17
Leak/Splash 15 15
Off-Label Use 15 15
Device Expiration Issue 15 15
Activation Problem 14 14
Complete Blockage 13 13
Partial Blockage 13 13
Difficult to Insert 12 12
Device-Device Incompatibility 11 11
Material Integrity Problem 9 9
Product Quality Problem 8 8
Mechanical Problem 8 8
Material Split, Cut or Torn 8 8
Noise, Audible 7 7
No Apparent Adverse Event 6 6
Inadequacy of Device Shape and/or Size 6 6
Delivered as Unsterile Product 6 6
Device Contamination with Chemical or Other Material 6 6
Device Markings/Labelling Problem 6 6
Self-Activation or Keying 5 5
Device Damaged Prior to Use 5 5
Separation Failure 5 5
Component Missing 5 5
Use of Device Problem 5 5
Device Difficult to Setup or Prepare 4 4
Loss of or Failure to Bond 4 4
Material Fragmentation 4 4
Torn Material 4 4
Defective Component 4 4
Unintended System Motion 4 4
Contamination 4 4
Device Contaminated During Manufacture or Shipping 4 4
Contamination /Decontamination Problem 3 3
Premature Separation 3 3
Component Falling 3 3
Dent in Material 3 3
Failure to Fire 3 3
Failure to Eject 3 3
Appropriate Term/Code Not Available 3 3
Device Packaging Compromised 3 3
Collapse 3 3
Labelling, Instructions for Use or Training Problem 3 3
Failure to Unfold or Unwrap 3 3
Difficult to Flush 2 2
Difficult to Open or Close 2 2
Device Handling Problem 2 2
Physical Property Issue 2 2
Therapy Delivered to Incorrect Body Area 2 2
Material Rupture 2 2
Device Inoperable 2 2
Compatibility Problem 2 2
Firing Problem 2 2
Unintended Movement 2 2
Material Distortion 1 1
Component Misassembled 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1974 1974
Reocclusion 287 287
Stenosis 255 255
Occlusion 251 252
No Known Impact Or Consequence To Patient 222 222
No Clinical Signs, Symptoms or Conditions 218 218
Claudication 215 215
Thrombosis 145 146
Pain 124 124
No Patient Involvement 121 121
Foreign Body In Patient 101 101
Death 70 70
Device Embedded In Tissue or Plaque 68 68
Patient Problem/Medical Problem 64 64
No Code Available 59 59
Vascular System (Circulation), Impaired 50 50
Injury 48 48
Ischemia 48 48
Unspecified Infection 40 40
Obstruction/Occlusion 39 39
Thrombus 39 39
Restenosis 38 38
Insufficient Information 32 32
Vessel Or Plaque, Device Embedded In 31 31
Hemorrhage/Bleeding 29 29
No Information 28 28
Perforation 28 28
Embolism 25 25
Thrombosis/Thrombus 23 23
Vascular Dissection 21 21
Hematoma 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Pseudoaneurysm 16 16
Intimal Dissection 15 15
Aneurysm 14 14
Respiratory Distress 13 13
Pneumonia 12 12
Tissue Damage 12 12
Rupture 12 12
Diminished Pulse Pressure 11 11
Perforation of Vessels 10 10
Septic Shock 9 9
Paraplegia 9 9
Myocardial Infarction 8 9
Fistula 8 8
Fever 8 8
Sepsis 7 7
Swelling 7 7
Low Blood Pressure/ Hypotension 6 7
Hypersensitivity/Allergic reaction 6 6
Vasoconstriction 6 6
Atrial Fibrillation 6 6
Blood Loss 6 6
Tissue Breakdown 6 6
Unspecified Tissue Injury 5 5
Stroke/CVA 5 5
Numbness 5 5
Calcium Deposits/Calcification 5 5
Failure of Implant 5 5
Renal Failure 4 4
Cardiac Arrest 4 4
Cardiogenic Shock 4 4
Impaired Healing 3 3
Reaction 3 3
Bacterial Infection 3 3
Abdominal Pain 3 3
Chest Pain 3 3
Headache 3 3
Fall 3 3
Hypovolemic Shock 3 3
High Blood Pressure/ Hypertension 3 3
Respiratory Failure 3 3
Embolism/Embolus 3 3
Unspecified Vascular Problem 2 2
Abdominal Distention 2 2
Aortic Dissection 2 2
Atrial Perforation 2 2
Fasciitis 2 2
Transient Ischemic Attack 2 2
Gangrene 2 2
Dehydration 2 2
Rash 2 2
Nausea 2 2
Necrosis 2 2
Angina 2 2
Arrhythmia 2 2
Cellulitis 2 2
Purulent Discharge 2 2
Complaint, Ill-Defined 2 2
Urinary Tract Infection 2 2
Test Result 2 2
Thromboembolism 1 1
Not Applicable 1 1
Hemorrhagic Stroke 1 1
Unspecified Blood or Lymphatic problem 1 1
Ruptured Aneurysm 1 1
Visual Impairment 1 1
Weakness 1 1
Heart Failure 1 1
Edema 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 Ev3, Inc. II Jun-23-2016
4 Medtronic Inc. II Nov-29-2017
5 Terumo Medical Corp II Nov-29-2016
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