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Device
coronary drug-eluting stent
Definition
Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
Product Code
NIQ
Device Class
3
Premarket Approvals (PMA)
2016
2017
2018
2019
2020
2021
72
53
61
59
62
11
MDR Year
MDR Reports
MDR Events
2016
7233
7233
2017
6786
6786
2018
6816
6816
2019
7254
7254
2020
6362
6362
2021
976
976
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
10777
10777
Material Deformation
6807
6807
Stent
5685
5685
Failure to Advance
5301
5301
Device Dislodged or Dislocated
4333
4333
Bent
3554
3554
Catheter
2415
2415
Difficult to Remove
1698
1698
Break
1546
1546
Occlusion Within Device
1170
1170
Device Damaged Prior to Use
895
895
Shaft
785
785
Difficult to Advance
631
631
Device Damaged by Another Device
626
626
Improper or Incorrect Procedure or Method
545
545
Inflation Problem
418
418
Activation, Positioning or SeparationProblem
399
399
Fracture
377
377
Material Rupture
371
371
Detachment Of Device Component
368
368
Material Separation
281
281
Deflation Problem
270
270
Balloon
244
244
Leak/Splash
232
232
Entrapment of Device
226
226
Difficult To Position
225
225
Obstruction of Flow
221
221
Detachment of Device or Device Component
217
217
Kinked
189
189
Activation Failure
169
169
Difficult or Delayed Positioning
130
130
Burst Container or Vessel
123
123
Migration or Expulsion of Device
109
109
Patient-Device Incompatibility
103
103
Positioning Failure
102
102
Material Twisted/Bent
101
101
Physical Resistance
93
93
Defective Device
90
90
Migration
69
69
Physical Resistance/Sticking
68
68
Stretched
68
68
Deformation Due to Compressive Stress
65
65
Malposition of Device
65
65
Material Integrity Problem
64
64
Device Expiration Issue
63
63
Unstable
59
59
Insufficient Information
55
55
Device-Device Incompatibility
50
50
Device Contamination with Chemical or Other Material
49
49
Use of Device Problem
47
47
Positioning Problem
46
46
Difficult to Insert
46
46
Device Markings/Labelling Problem
40
40
Torn Material
37
37
Device Operates Differently Than Expected
34
34
Difficult or Delayed Activation
33
33
Component Missing
30
30
Tip
29
29
Premature Activation
28
28
Tear, Rip or Hole in Device Packaging
26
26
Material Split, Cut or Torn
24
24
Patient Device Interaction Problem
22
22
Product Quality Problem
19
19
Appropriate Term/Code Not Available
18
18
Off-Label Use
18
18
Device Or Device Fragments Location Unknown
17
17
Defective Component
17
17
Inadequacy of Device Shape and/or Size
16
16
Contamination
16
16
Contamination /Decontamination Problem
15
15
Device Misassembled During Manufacturing /Shipping
15
15
Crack
14
14
Unsealed Device Packaging
13
13
Unintended System Motion
13
13
Physical Property Issue
11
11
Hole In Material
10
10
Peeled/Delaminated
10
10
Loose or Intermittent Connection
9
9
Material Distortion
9
9
Unintended Movement
9
9
Packaging Problem
9
9
Material Protrusion/Extrusion
8
8
Device Slipped
8
8
Material Puncture/Hole
8
8
Retraction Problem
8
8
Inaccurate Delivery
7
7
Difficult to Open or Remove Packaging Material
7
7
No Apparent Adverse Event
7
7
Failure to Fold
7
7
Sticking
6
6
Label
6
6
Wire
6
6
Guidewire
6
6
Mechanical Jam
6
6
Fluid Leak
6
6
Mechanical Problem
5
5
Expulsion
5
5
Human-Device Interface Problem
5
5
Folded
5
5
Device Packaging Compromised
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
18391
18391
Myocardial Infarction
2852
2853
Intimal Dissection
2647
2647
Death
2283
2283
No Patient Involvement
1906
1906
Thrombosis
1698
1698
Angina
1542
1542
No Known Impact Or Consequence To Patient
911
911
Stenosis
847
847
No Clinical Signs, Symptoms or Conditions
796
796
Occlusion
767
767
Reocclusion
705
705
Chest Pain
665
665
Patient Problem/Medical Problem
621
621
Thrombus
586
586
Stroke/CVA
474
474
Vascular Dissection
471
471
Dyspnea
398
398
Injury
383
383
Cardiac Arrest
362
362
No Code Available
349
349
Blood Loss
328
328
Cardiac Enzyme Elevation
256
256
Obstruction/Occlusion
203
203
Low Blood Pressure/ Hypotension
202
202
Foreign Body In Patient
201
201
ST Segment Elevation
196
196
Ischemia
176
176
Device Embedded In Tissue or Plaque
176
176
Perforation
152
152
Non specific EKG/ECG Changes
141
141
Heart Failure
136
136
Ventricular Fibrillation
115
115
Vessel Or Plaque, Device Embedded In
115
115
Hypersensitivity/Allergic reaction
107
107
Cardiogenic Shock
105
105
Bradycardia
99
99
Insufficient Information
99
99
Arrhythmia
96
96
Thrombosis/Thrombus
94
94
Embolism
92
92
Hemorrhage/Bleeding
87
87
High Blood Pressure/ Hypertension
84
84
Congestive Heart Failure
84
84
Ventricular Tachycardia
84
84
Reaction
82
82
Nausea
72
72
Prolapse
70
70
Atrial Fibrillation
67
67
Respiratory Failure
62
62
Perforation of Vessels
52
52
Unspecified Tissue Injury
52
52
Pain
48
48
Fatigue
48
48
Diaphoresis
46
46
Cardiopulmonary Arrest
46
46
No Information
44
44
Dizziness
40
40
Aneurysm
40
40
Cardiac Tamponade
39
39
Hematoma
36
36
Vasoconstriction
35
35
Test Result
35
35
Pneumonia
33
33
Renal Failure
33
33
Unspecified Infection
32
32
Syncope
32
32
Atherosclerosis
27
27
Weakness
27
27
Chest Tightness/Pressure
27
27
Complaint, Ill-Defined
26
26
Respiratory Distress
26
26
Pericardial Effusion
25
25
Sudden Cardiac Death
23
23
Sepsis
23
23
Cardiomyopathy
23
23
Pulmonary Edema
23
23
Pseudoaneurysm
22
22
Rash
22
22
Tachycardia
19
19
Vomiting
19
19
Rupture
18
18
Shock
17
17
Edema
17
17
ST Segment Depression
17
17
Anemia
16
16
Loss Of Pulse
15
15
Restenosis
15
15
Headache
15
15
Inflammation
14
14
Numbness
14
14
Neurological Deficit/Dysfunction
13
13
Ischemic Heart Disease
13
13
Fever
11
11
Calcium Deposits/Calcification
10
10
Infarction, Cerebral
9
9
Discomfort
9
9
Hypoxia
9
9
Air Embolism
8
8
Atrial Flutter
8
8
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Vascular
II
Jun-15-2020
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