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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)
2019
2020
2021
2022
2023
2024
59
62
63
45
49
9
MDR Year
MDR Reports
MDR Events
2019
7254
7254
2020
6362
6362
2021
5268
5268
2022
4068
4153
2023
3096
3096
2024
839
839
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
8730
8730
Material Deformation
7784
7784
Failure to Advance
5046
5046
Device Dislodged or Dislocated
3321
3321
Difficult to Remove
1728
1728
Break
1536
1536
Difficult to Advance
1050
1050
Improper or Incorrect Procedure or Method
439
439
Material Separation
404
404
Material Rupture
376
376
Fracture
375
375
Inflation Problem
373
373
Activation Failure
358
358
Detachment of Device or Device Component
310
310
Device Damaged by Another Device
285
285
Obstruction of Flow
258
258
Deflation Problem
244
244
Activation, Positioning or Separation Problem
225
225
Leak/Splash
214
214
Entrapment of Device
213
213
Positioning Problem
207
207
Burst Container or Vessel
151
151
Patient-Device Incompatibility
140
225
Device-Device Incompatibility
131
131
Defective Device
118
118
Material Integrity Problem
113
113
Deformation Due to Compressive Stress
100
100
Use of Device Problem
95
95
Migration
93
93
Material Split, Cut or Torn
80
80
Positioning Failure
69
69
Difficult to Insert
62
62
Stretched
61
61
Difficult or Delayed Activation
59
59
Migration or Expulsion of Device
52
52
Patient Device Interaction Problem
51
51
Failure to Deflate
47
47
Off-Label Use
44
44
Difficult or Delayed Positioning
40
40
Device Markings/Labelling Problem
38
38
Malposition of Device
35
35
Premature Activation
33
33
Physical Resistance/Sticking
33
33
Device Contamination with Chemical or Other Material
32
32
Product Quality Problem
27
27
Contamination
23
23
Component Missing
23
23
Material Puncture/Hole
19
19
Insufficient Information
18
18
Packaging Problem
18
18
Difficult to Open or Remove Packaging Material
18
18
Unsealed Device Packaging
16
16
No Apparent Adverse Event
16
16
Unintended System Motion
15
15
Material Twisted/Bent
15
15
Tear, Rip or Hole in Device Packaging
14
14
Defective Component
13
13
Fluid/Blood Leak
13
13
Material Too Soft/Flexible
12
12
Inadequacy of Device Shape and/or Size
11
11
Wrong Label
9
9
Loose or Intermittent Connection
9
9
Contamination /Decontamination Problem
9
9
Unintended Movement
7
7
Material Too Rigid or Stiff
7
7
Failure to Fold
6
6
Component Misassembled
6
6
Activation Problem
5
5
Retraction Problem
5
5
Expiration Date Error
5
5
Structural Problem
4
4
Unraveled Material
4
4
Mechanical Jam
4
4
Device Misassembled During Manufacturing /Shipping
4
4
Mechanical Problem
4
4
Device Slipped
3
3
Device Damaged Prior to Use
3
3
Device Contaminated During Manufacture or Shipping
3
3
Peeled/Delaminated
3
3
Material Protrusion/Extrusion
3
3
Separation Failure
3
3
Device Difficult to Setup or Prepare
3
3
Therapeutic or Diagnostic Output Failure
3
3
Appropriate Term/Code Not Available
3
3
Human-Device Interface Problem
3
3
Infusion or Flow Problem
3
3
Device Fell
2
2
Difficult to Flush
2
2
Failure to Eject
2
2
Failure to Deliver
2
2
Poor Visibility
2
2
Material Frayed
2
2
Therapy Delivered to Incorrect Body Area
2
2
Failure to Unfold or Unwrap
2
2
Material Perforation
2
2
Noise, Audible
1
1
Crack
1
1
Collapse
1
1
Disconnection
1
1
Premature Separation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
8551
8551
No Consequences Or Impact To Patient
7510
7510
Vascular Dissection
2463
2463
Myocardial Infarction
2066
2151
Intimal Dissection
995
995
Insufficient Information
887
887
Angina
868
868
Death
803
803
Thrombosis/Thrombus
623
708
Thrombosis
540
540
Stenosis
521
521
No Patient Involvement
416
416
No Known Impact Or Consequence To Patient
392
392
Occlusion
378
378
Injury
376
376
Stroke/CVA
355
440
Obstruction/Occlusion
287
287
Cardiac Arrest
268
268
Restenosis
267
267
Chest Pain
254
254
Thrombus
243
243
No Code Available
228
228
Foreign Body In Patient
204
204
Blood Loss
191
191
Device Embedded In Tissue or Plaque
191
191
Unspecified Tissue Injury
169
169
Ischemia
153
153
Hemorrhage/Bleeding
134
134
Low Blood Pressure/ Hypotension
125
125
Perforation
117
117
Non specific EKG/ECG Changes
114
114
Dyspnea
110
110
Cardiac Enzyme Elevation
92
92
Reocclusion
77
77
Perforation of Vessels
75
75
Heart Failure/Congestive Heart Failure
75
75
Arteriosclerosis/ Atherosclerosis
70
70
Arrhythmia
63
63
Bradycardia
62
62
Hypersensitivity/Allergic reaction
62
62
Ventricular Fibrillation
61
61
Cardiogenic Shock
60
60
Prolapse
59
59
High Blood Pressure/ Hypertension
59
59
Embolism
51
51
Patient Problem/Medical Problem
50
50
Heart Failure
48
48
Pain
46
46
Aneurysm
43
43
Vessel Or Plaque, Device Embedded In
38
38
Local Reaction
38
38
Hematoma
38
38
Atrial Fibrillation
32
32
Respiratory Failure
32
32
Embolism/Embolus
31
31
Pneumonia
29
29
Cardiac Tamponade
28
28
Tachycardia
27
27
Ventricular Tachycardia
26
26
Pericardial Effusion
26
26
Reaction
25
25
Complaint, Ill-Defined
23
23
Rash
23
23
Unspecified Infection
23
23
Rupture
21
21
Atherosclerosis
20
20
ST Segment Elevation
19
19
Nausea
18
18
Failure of Implant
18
18
Ischemic Heart Disease
17
17
Pseudoaneurysm
16
16
Sepsis
16
16
Discomfort
15
15
Test Result
15
15
Atrial Flutter
15
15
Fatigue
14
14
Diaphoresis
14
14
Shock
14
14
Vasoconstriction
14
14
Swelling/ Edema
13
13
Unspecified Heart Problem
11
11
Dizziness
11
11
Transient Ischemic Attack
11
11
Fever
11
11
Cardiopulmonary Arrest
11
11
Inflammation
10
10
Renal Failure
10
10
Pulmonary Edema
9
9
Anemia
9
9
Syncope
9
9
Headache
8
8
Neurological Deficit/Dysfunction
7
7
No Information
7
7
Respiratory Arrest
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Sudden Cardiac Death
6
6
Anxiety
6
6
Respiratory Distress
6
6
Hypoxia
6
6
Hemoptysis
5
5
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Vascular
II
Jun-15-2020
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