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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, drug-eluting
Definition Stent, Superficial Femoral Artery, Drug-Eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen. The drug coating is intended to inhibit restenosis.
Product CodeNIU
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
20 22 9 5 7 1

MDR Year MDR Reports MDR Events
2019 295 295
2020 319 319
2021 225 225
2022 254 254
2023 248 248
2024 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 718 718
Activation, Positioning or Separation Problem 207 207
Material Deformation 189 189
Fracture 113 113
Entrapment of Device 70 70
Activation Failure 46 46
Premature Activation 44 44
Off-Label Use 44 44
Improper or Incorrect Procedure or Method 43 43
Obstruction of Flow 33 33
Difficult to Remove 30 30
Failure to Advance 26 26
Difficult or Delayed Positioning 25 25
Structural Problem 22 22
Appropriate Term/Code Not Available 22 22
Difficult to Advance 22 22
Positioning Problem 21 21
Material Integrity Problem 18 18
Break 17 17
Difficult or Delayed Activation 15 15
Deformation Due to Compressive Stress 14 14
Use of Device Problem 14 14
Defective Device 12 12
Positioning Failure 11 11
Detachment of Device or Device Component 9 9
Migration 9 9
Physical Resistance/Sticking 9 9
Insufficient Information 8 8
Device-Device Incompatibility 6 6
Difficult to Insert 6 6
Device Markings/Labelling Problem 5 5
Stretched 5 5
Patient Device Interaction Problem 5 5
Device Contamination with Chemical or Other Material 4 4
Poor Visibility 4 4
Expiration Date Error 4 4
Retraction Problem 4 4
Biocompatibility 3 3
Dent in Material 3 3
Unsealed Device Packaging 2 2
Partial Blockage 2 2
Collapse 2 2
Compatibility Problem 2 2
Material Twisted/Bent 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Activation Problem 2 2
No Apparent Adverse Event 1 1
Mechanical Jam 1 1
Failure to Shut Off 1 1
Contamination 1 1
Complete Blockage 1 1
Material Fragmentation 1 1
Material Separation 1 1
Device Damaged Prior to Use 1 1
Tear, Rip or Hole in Device Packaging 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 372 372
Restenosis 211 211
No Consequences Or Impact To Patient 164 164
Obstruction/Occlusion 138 138
Reocclusion 121 121
Thrombosis/Thrombus 114 114
Thrombosis 100 100
Pain 96 96
Occlusion 81 81
No Known Impact Or Consequence To Patient 73 73
Stenosis 42 42
Ischemia 41 41
Arteriosclerosis/ Atherosclerosis 40 40
No Code Available 35 35
Claudication 32 32
Insufficient Information 23 23
Vascular Dissection 22 22
Aneurysm 20 20
No Information 19 19
Pseudoaneurysm 19 19
Numbness 12 12
Foreign Body In Patient 11 11
Embolism/Embolus 11 11
Hemorrhage/Bleeding 10 10
Swelling/ Edema 9 9
Ulcer 8 8
Hypersensitivity/Allergic reaction 8 8
Discomfort 6 6
Injury 5 5
Unspecified Vascular Problem 5 5
Device Embedded In Tissue or Plaque 5 5
Inflammation 5 5
Embolism 5 5
Necrosis 5 5
Muscle Weakness 4 4
Vasoconstriction 4 4
Death 4 4
Hematoma 4 4
Disability 4 4
Hypovolemia 4 4
Movement Disorder 3 3
Ruptured Aneurysm 3 3
Skin Inflammation/ Irritation 3 3
Failure of Implant 3 3
Reaction to Medicinal Component of Device 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Dyspnea 2 2
Embolus 2 2
Fatigue 2 2
Perforation of Vessels 2 2
Thrombus 2 2
Perforation 2 2
Unspecified Heart Problem 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Paresthesia 2 2
Dizziness 2 2
Post Operative Wound Infection 2 2
Tissue Breakdown 2 2
Patient Problem/Medical Problem 1 1
No Patient Involvement 1 1
Thromboembolism 1 1
Blood Loss 1 1
Reaction 1 1
Unspecified Tissue Injury 1 1
Rash 1 1
Renal Failure 1 1
Shock 1 1
Swelling 1 1
Neuropathy 1 1
Muscle Spasm(s) 1 1
Tingling 1 1
Rupture 1 1
Fever 1 1
Foreign Body Reaction 1 1
Bacterial Infection 1 1
Unspecified Infection 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Hyperplasia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II May-18-2021
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