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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 2

MDR Year MDR Reports MDR Events
2016 846 846
2017 789 789
2018 546 546
2019 716 716
2020 798 798
2021 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 675 675
Activation, Positioning or SeparationProblem 412 412
Stent 400 400
Fracture 372 372
Positioning Failure 331 331
Difficult to Remove 324 324
Material Deformation 320 320
Break 266 266
Activation Failure 235 235
Material Separation 220 220
Detachment Of Device Component 216 216
Premature Activation 188 188
Improper or Incorrect Procedure or Method 180 180
Occlusion Within Device 172 172
Difficult or Delayed Positioning 171 171
Stretched 168 168
Entrapment of Device 124 124
Difficult or Delayed Activation 115 115
Catheter 105 105
Failure to Advance 93 93
Detachment of Device or Device Component 86 86
Difficult to Advance 83 83
Bent 78 78
Mechanical Jam 71 71
Material Twisted/Bent 69 69
Physical Resistance/Sticking 65 65
Device Operates Differently Than Expected 56 56
Obstruction of Flow 56 56
Positioning Problem 53 53
Misfire 53 53
Malposition of Device 52 52
Migration 41 41
Material Torqued 38 38
Patient-Device Incompatibility 36 36
Insufficient Information 36 36
Defective Device 35 35
Migration or Expulsion of Device 28 28
Device Dislodged or Dislocated 26 26
Device Damaged by Another Device 26 26
Kinked 24 24
Difficult To Position 23 23
Retraction Problem 20 20
Inaccurate Delivery 18 18
Physical Resistance 17 17
Deformation Due to Compressive Stress 17 17
Tip 17 17
Tear, Rip or Hole in Device Packaging 17 17
Sticking 17 17
Device Expiration Issue 15 15
Off-Label Use 14 14
Activation Problem 14 14
Complete Blockage 12 12
Partial Blockage 12 12
Device-Device Incompatibility 11 11
Device Deployer 10 10
Shaft 10 10
Difficult to Insert 10 10
Leak/Splash 8 8
Material Integrity Problem 8 8
Mechanical Problem 8 8
Material Split, Cut or Torn 7 7
No Apparent Adverse Event 6 6
Device Markings/Labelling Problem 6 6
Product Quality Problem 6 6
Delivered as Unsterile Product 6 6
Inadequacy of Device Shape and/or Size 6 6
Device Damaged Prior to Use 5 5
Self-Activation or Keying 5 5
Wire 5 5
Use of Device Problem 5 5
Component Missing 5 5
Noise, Audible 5 5
Separation Failure 4 4
Torn Material 4 4
Device Difficult to Setup or Prepare 4 4
Loss of or Failure to Bond 4 4
Unintended System Motion 4 4
Defective Component 4 4
Device Contamination with Chemical or Other Material 4 4
Device Contaminated During Manufacture or Shipping 4 4
Premature Separation 3 3
Contamination /Decontamination Problem 3 3
Failure to Fire 3 3
Dent in Material 3 3
Component Falling 3 3
Contamination 3 3
Balloon 3 3
Labelling, Instructions for Use or Training Problem 3 3
Device Packaging Compromised 3 3
Failure to Eject 3 3
Appropriate Term/Code Not Available 3 3
Device Handling Problem 2 2
Difficult to Open or Close 2 2
Physical Property Issue 2 2
Failure to Unfold or Unwrap 2 2
Material Fragmentation 2 2
Guidewire 2 2
Device Inoperable 2 2
Therapy Delivered to Incorrect Body Area 2 2
Material Rupture 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1974 1974
Reocclusion 287 287
Occlusion 251 252
Stenosis 233 233
No Known Impact Or Consequence To Patient 221 221
Claudication 215 215
Thrombosis 144 145
No Patient Involvement 121 121
Pain 118 118
Foreign Body In Patient 91 91
No Clinical Signs, Symptoms or Conditions 79 79
Death 70 70
Device Embedded In Tissue or Plaque 67 67
Patient Problem/Medical Problem 64 64
No Code Available 59 59
Vascular System (Circulation), Impaired 50 50
Injury 48 48
Ischemia 46 46
Thrombus 39 39
Vessel Or Plaque, Device Embedded In 31 31
Unspecified Infection 30 30
No Information 28 28
Perforation 26 26
Embolism 25 25
Hemorrhage/Bleeding 24 24
Restenosis 22 22
Hematoma 19 19
Pseudoaneurysm 16 16
Intimal Dissection 15 15
Vascular Dissection 15 15
Obstruction/Occlusion 14 14
Respiratory Distress 13 13
Pneumonia 12 12
Aneurysm 12 12
Diminished Pulse Pressure 11 11
Tissue Damage 11 11
Rupture 10 10
Septic Shock 9 9
Perforation of Vessels 9 9
Paraplegia 9 9
Myocardial Infarction 7 8
Fistula 7 7
Swelling 7 7
Sepsis 7 7
Fever 6 6
Low Blood Pressure/ Hypotension 6 7
Vasoconstriction 6 6
Atrial Fibrillation 6 6
Blood Loss 6 6
Stroke/CVA 5 5
Numbness 5 5
Hypersensitivity/Allergic reaction 5 5
Calcium Deposits/Calcification 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Respiratory Failure 3 3
Fall 3 3
Renal Failure 3 3
Bacterial Infection 3 3
Cardiac Arrest 3 3
Abdominal Pain 3 3
Chest Pain 3 3
Headache 3 3
Impaired Healing 3 3
Reaction 3 3
Complaint, Ill-Defined 2 2
Test Result 2 2
Necrosis 2 2
Urinary Tract Infection 2 2
Angina 2 2
Arrhythmia 2 2
Cellulitis 2 2
Purulent Discharge 2 2
Rash 2 2
Transient Ischemic Attack 2 2
Dehydration 2 2
High Blood Pressure/ Hypertension 2 2
Gangrene 2 2
Fasciitis 2 2
Abdominal Distention 2 2
Atrial Perforation 2 2
Insufficient Information 2 2
Embolism/Embolus 2 2
Thrombosis/Thrombus 1 1
Ambulation Difficulties 1 1
Cancer 1 1
Pericardial Effusion 1 1
Extubate 1 1
Aortic Dissection 1 1
Prolapse 1 1
Hearing Loss 1 1
Hypovolemic Shock 1 1
Failure of Implant 1 1
Neurological Deficit/Dysfunction 1 1
Neuropathy 1 1
Dyspnea 1 1
Extravasation 1 1
Congestive Heart Failure 1 1
Erosion 1 1
Pulmonary Embolism 1 1
Anemia 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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