Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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 Code
NIU
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
Improper or Incorrect Procedure or Method
52
52
Obstruction of Flow
52
52
Device Operates Differently Than Expected
46
46
Insufficient Information
45
45
Off-Label Use
45
45
Stretched
43
43
Break
34
34
Difficult or Delayed Positioning
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
Material Integrity Problem
19
19
Bent
19
19
Positioning Failure
18
18
Deformation Due to Compressive Stress
16
16
Use of Device Problem
16
16
Difficult or Delayed Activation
15
15
Defective Device
13
13
Detachment of Device or Device Component
10
10
Physical Resistance/Sticking
10
10
Migration
10
10
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
Device Contamination with Chemical or Other Material
5
5
Kinked
5
5
Packaging Problem
5
5
Patient Device Interaction Problem
5
5
Difficult to Open or Remove Packaging Material
5
5
Device Markings/Labelling Problem
5
5
Expiration Date Error
5
5
Therapeutic or Diagnostic Output Failure
4
4
Retraction Problem
4
4
Poor Visibility
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
Device Embedded In Tissue or Plaque
27
27
Foreign Body In Patient
27
27
Insufficient Information
24
24
No Information
24
24
Ulcer
16
16
Numbness
16
16
Ulceration
14
14
Swelling/ Edema
13
13
Hemorrhage/Bleeding
12
12
Embolism/Embolus
11
11
Amputation
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
Vasoconstriction
5
5
Hematoma
5
5
Unspecified Vascular Problem
5
5
Rash
5
5
Disability
4
4
Surgery, prolonged
4
4
Aspiration/Inhalation
4
4
Failure of Implant
4
4
Muscle Weakness
4
4
Surgical procedure
4
4
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
May-18-2021
2
Cook, Inc.
I
May-15-2013
-
-