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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 1 8 0 6 5 4 10 20 22 9 5 7 1

MDR Year MDR Reports MDR Events
2014 169 169
2015 168 168
2016 232 232
2017 279 279
2018 194 194
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 804 804
Occlusion Within Device 465 465
Activation, Positioning or Separation Problem 383 383
Fracture 262 262
Material Deformation 198 198
Entrapment of Device 85 85
Difficult to Remove 55 55
Premature Activation 52 52
Obstruction of Flow 52 52
Activation Failure 52 52
Device Operates Differently Than Expected 46 46
Improper or Incorrect Procedure or Method 45 45
Insufficient Information 45 45
Off-Label Use 44 44
Stretched 43 43
Difficult or Delayed Positioning 33 33
Break 32 32
Appropriate Term/Code Not Available 31 31
Delivery System Failure 30 30
Failure to Advance 26 26
Positioning Problem 25 25
Difficult to Advance 24 24
Structural Problem 22 22
Material Integrity Problem 19 19
Bent 19 19
Positioning Failure 16 16
Use of Device Problem 16 16
Deformation Due to Compressive Stress 15 15
Difficult or Delayed Activation 15 15
Defective Device 13 13
Migration 10 10
Physical Resistance/Sticking 9 9
Detachment of Device or Device Component 9 9
Device Expiration Issue 8 8
Partial Blockage 6 6
Difficult to Insert 6 6
Device-Device Incompatibility 6 6
No Apparent Adverse Event 5 5
Patient Device Interaction Problem 5 5
Kinked 5 5
Expiration Date Error 5 5
Packaging Problem 5 5
Difficult to Open or Remove Packaging Material 5 5
Device Contamination with Chemical or Other Material 5 5
Device Markings/Labelling Problem 5 5
Device Packaging Compromised 4 4
Malposition of Device 4 4
Retraction Problem 4 4
Migration or Expulsion of Device 4 4
Therapeutic or Diagnostic Output Failure 4 4
Poor Visibility 4 4
Mechanical Problem 3 3
Collapse 3 3
Detachment Of Device Component 3 3
Restricted Flow rate 3 3
Dent in Material 3 3
Biocompatibility 3 3
Improper Flow or Infusion 3 3
Compatibility Problem 3 3
Infusion or Flow Problem 3 3
Material Twisted/Bent 2 2
Device Disinfection Or Sterilization Issue 2 2
Material Fragmentation 2 2
Unsealed Device Packaging 2 2
Shelf Life Exceeded 2 2
Unexpected Therapeutic Results 2 2
Activation Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Material Perforation 1 1
Device Damaged Prior to Use 1 1
Implant, removal of 1 1
Tear, Rip or Hole in Device Packaging 1 1
Material Separation 1 1
Difficult to Fold, Unfold or Collapse 1 1
Contamination 1 1
Degraded 1 1
Complete Blockage 1 1
Contamination /Decontamination Problem 1 1
Folded 1 1
Mechanical Jam 1 1
No Flow 1 1
Device Damaged by Another Device 1 1
Human-Device Interface Problem 1 1
Failure to Shut Off 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Reocclusion 494 495
No Clinical Signs, Symptoms or Conditions 372 372
No Consequences Or Impact To Patient 345 345
Occlusion 224 224
Restenosis 212 212
No Known Impact Or Consequence To Patient 201 201
Thrombosis 177 177
Claudication 172 173
Surgical procedure, additional 166 166
Obstruction/Occlusion 138 138
Pain 127 127
Thrombosis/Thrombus 119 119
Stenosis 81 82
No Code Available 62 62
Ischemia 45 45
Arteriosclerosis/ Atherosclerosis 42 42
Device Embedded In Tissue or Plaque 26 26
Aneurysm 25 25
Pseudoaneurysm 25 25
Foreign Body In Patient 25 25
No Information 24 24
Vascular Dissection 24 24
Insufficient Information 24 24
Ulceration 14 14
Numbness 13 13
Ulcer 12 12
Hemorrhage/Bleeding 12 12
Amputation 11 11
Embolism/Embolus 11 11
Swelling/ Edema 9 9
Hypersensitivity/Allergic reaction 8 8
Thrombus 8 8
Discomfort 7 7
Death 7 7
Embolism 6 6
Inflammation 6 6
Injury 6 6
Vasoconstriction 5 5
Unspecified Infection 5 5
Necrosis 5 5
Rash 5 5
Unspecified Vascular Problem 5 5
Muscle Weakness 4 4
Hematoma 4 4
Aspiration/Inhalation 4 4
Perforation of Vessels 4 4
Surgery, prolonged 4 4
Surgical procedure 4 4
Disability 4 4
Hypovolemia 4 4
Therapy/non-surgical treatment, additional 4 4
Treatment with medication(s) 3 3
Embolus 3 3
Failure of Implant 3 3
Perforation 3 3
Skin Inflammation/ Irritation 3 3
Ruptured Aneurysm 3 3
Reaction to Medicinal Component of Device 3 3
Movement Disorder 3 3
Paresthesia 2 2
Unspecified Heart Problem 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Fatigue 2 2
Bleeding 2 2
Dyspnea 2 2
Gangrene 2 2
High Blood Pressure/ Hypertension 2 2
Low Blood Pressure/ Hypotension 2 2
Blood Loss 2 2
No Patient Involvement 2 2
Tissue Breakdown 2 2
Rupture 2 2
Post Operative Wound Infection 2 2
Reaction 2 2
Dizziness 2 2
Tingling 2 2
Blockage 1 1
Surgical procedure, delayed 1 1
Patient Problem/Medical Problem 1 1
Thromboembolism 1 1
Clotting 1 1
Hyperplasia 1 1
Edema 1 1
Cellulitis 1 1
Infarction, Cerebral 1 1
Bacterial Infection 1 1
Fever 1 1
Foreign Body Reaction 1 1
Renal Failure 1 1
Sepsis 1 1
Shock 1 1
Swelling 1 1
Neuropathy 1 1
Muscle Spasm(s) 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II May-18-2021
2 Cook, Inc. I May-15-2013
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