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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 2

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 129 129

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 851 851
Occlusion Within Device 465 465
Activation, Positioning or Separation Problem 407 407
Fracture 272 272
Material Deformation 215 215
Entrapment of Device 90 90
Activation Failure 66 66
Difficult to Remove 62 62
Premature Activation 56 56
Obstruction of Flow 52 52
Improper or Incorrect Procedure or Method 52 52
Device Operates Differently Than Expected 46 46
Insufficient Information 45 45
Off-Label Use 45 45
Stretched 43 43
Difficult or Delayed Positioning 34 34
Break 34 34
Appropriate Term/Code Not Available 31 31
Delivery System Failure 30 30
Positioning Problem 27 27
Failure to Advance 26 26
Difficult to Advance 24 24
Structural Problem 23 23
Bent 19 19
Material Integrity Problem 19 19
Positioning Failure 18 18
Use of Device Problem 16 16
Deformation Due to Compressive Stress 16 16
Difficult or Delayed Activation 15 15
Defective Device 13 13
Detachment of Device or Device Component 10 10
Migration 10 10
Physical Resistance/Sticking 10 10
Device Expiration Issue 8 8
Partial Blockage 6 6
Device-Device Incompatibility 6 6
Difficult to Insert 6 6
No Apparent Adverse Event 5 5
Device Contamination with Chemical or Other Material 5 5
Device Markings/Labelling Problem 5 5
Expiration Date Error 5 5
Kinked 5 5
Packaging Problem 5 5
Patient Device Interaction Problem 5 5
Difficult to Open or Remove Packaging Material 5 5
Retraction Problem 4 4
Poor Visibility 4 4
Therapeutic or Diagnostic Output Failure 4 4
Migration or Expulsion of Device 4 4
Malposition of Device 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Reocclusion 494 495
No Clinical Signs, Symptoms or Conditions 415 415
No Consequences Or Impact To Patient 345 345
Restenosis 237 237
Occlusion 224 224
No Known Impact Or Consequence To Patient 201 201
Thrombosis 177 177
Claudication 172 173
Surgical procedure, additional 166 166
Obstruction/Occlusion 151 151
Pain 139 139
Thrombosis/Thrombus 126 126
Stenosis 81 82
No Code Available 62 62
Arteriosclerosis/ Atherosclerosis 52 52
Ischemia 50 50
Vascular Dissection 30 30
Aneurysm 28 28
Pseudoaneurysm 28 28
Foreign Body In Patient 27 27
Device Embedded In Tissue or Plaque 27 27
No Information 24 24
Insufficient Information 24 24
Ulcer 16 16
Numbness 16 16
Ulceration 14 14
Swelling/ Edema 13 13
Hemorrhage/Bleeding 12 12
Amputation 11 11
Embolism/Embolus 11 11
Hypersensitivity/Allergic reaction 8 8
Thrombus 8 8
Unspecified Infection 8 8
Ruptured Aneurysm 7 7
Death 7 7
Discomfort 7 7
Embolism 6 6
Inflammation 6 6
Injury 6 6
Necrosis 5 5
Hematoma 5 5
Vasoconstriction 5 5
Unspecified Vascular Problem 5 5
Rash 5 5
Perforation of Vessels 4 4
Hypovolemia 4 4
Failure of Implant 4 4
Therapy/non-surgical treatment, additional 4 4
Disability 4 4
Aspiration/Inhalation 4 4

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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