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TPLC
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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 Code
NIP
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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