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TPLC
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Device
stent, carotid
Definition
Stent, Carotid -- a metal scaffold placed via a delivery catheter into the carotid artery to maintain the lumen
Product Code
NIM
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
11
7
13
17
14
3
MDR Year
MDR Reports
MDR Events
2019
181
181
2020
163
163
2021
201
201
2022
172
172
2023
172
172
2024
34
34
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
287
287
Activation, Positioning or Separation Problem
103
103
Difficult or Delayed Positioning
94
94
Material Deformation
73
73
Difficult to Advance
53
53
Activation Failure
51
51
Break
48
48
Premature Activation
47
47
Difficult to Remove
47
47
Detachment of Device or Device Component
46
46
Positioning Failure
42
42
Material Separation
41
41
Fracture
23
23
Entrapment of Device
22
22
Malposition of Device
20
20
Mechanical Jam
19
19
Failure to Advance
18
18
Mechanical Problem
16
16
Positioning Problem
11
11
Migration
11
11
Defective Device
11
11
Deformation Due to Compressive Stress
10
10
Device Dislodged or Dislocated
9
9
Material Split, Cut or Torn
9
9
Physical Resistance/Sticking
9
9
Material Integrity Problem
8
8
Device Contamination with Chemical or Other Material
7
7
Migration or Expulsion of Device
7
7
Difficult to Insert
6
6
Difficult or Delayed Activation
6
6
Crack
5
5
Improper or Incorrect Procedure or Method
5
5
Material Frayed
5
5
Patient-Device Incompatibility
5
5
Device-Device Incompatibility
4
4
Loss of or Failure to Bond
4
4
Leak/Splash
4
4
Use of Device Problem
4
4
Off-Label Use
4
4
Tear, Rip or Hole in Device Packaging
3
3
Unsealed Device Packaging
3
3
Difficult to Open or Remove Packaging Material
3
3
Device Markings/Labelling Problem
2
2
Device Damaged by Another Device
2
2
Therapeutic or Diagnostic Output Failure
2
2
Activation Problem
2
2
Loose or Intermittent Connection
2
2
Contamination
2
2
Difficult to Flush
2
2
Obstruction of Flow
2
2
Component Missing
2
2
Device Difficult to Setup or Prepare
2
2
Material Puncture/Hole
1
1
Stretched
1
1
Retraction Problem
1
1
Collapse
1
1
Accessory Incompatible
1
1
Partial Blockage
1
1
Poor Visibility
1
1
Material Twisted/Bent
1
1
Patient Device Interaction Problem
1
1
Ambient Temperature Problem
1
1
Difficult to Open or Close
1
1
Compatibility Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
361
361
No Consequences Or Impact To Patient
180
180
Thrombosis/Thrombus
94
94
Stroke/CVA
92
92
Ischemia Stroke
59
59
Transient Ischemic Attack
38
38
Patient Problem/Medical Problem
36
36
Stenosis
33
33
Vascular Dissection
29
29
Myocardial Infarction
28
28
Obstruction/Occlusion
26
26
Restenosis
22
22
Thrombosis
21
21
No Patient Involvement
19
19
Low Blood Pressure/ Hypotension
17
17
Insufficient Information
17
17
Hematoma
16
16
Brain Injury
16
16
Occlusion
14
14
Bradycardia
14
14
Foreign Body In Patient
13
13
No Known Impact Or Consequence To Patient
13
13
Pain
11
11
Thrombus
10
10
Intracranial Hemorrhage
10
10
Unspecified Tissue Injury
9
9
Embolism/Embolus
8
8
Death
8
8
Embolism
8
8
Blood Loss
8
8
Renal Failure
7
7
Arrhythmia
6
6
High Blood Pressure/ Hypertension
6
6
Hemorrhage/Bleeding
5
5
Dysphasia
5
5
Device Embedded In Tissue or Plaque
5
5
Dizziness
4
4
Paresis
4
4
Reocclusion
4
4
Vasoconstriction
4
4
Perforation of Vessels
4
4
Neurological Deficit/Dysfunction
4
4
Ischemia
4
4
Extravasation
4
4
Cardiac Arrest
3
3
Aneurysm
3
3
Unspecified Infection
3
3
Headache
3
3
Paralysis
3
3
Perforation
3
3
Seizures
3
3
Injury
3
3
Rupture
3
3
Neck Pain
3
3
Pseudoaneurysm
3
3
Nervous System Injury
3
3
Hemorrhagic Stroke
3
3
Convulsion/Seizure
3
3
Unspecified Nervous System Problem
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Swelling/ Edema
2
2
Speech Disorder
2
2
No Information
2
2
Prolapse
2
2
Thromboembolism
2
2
Visual Impairment
2
2
Loss of Vision
2
2
Tissue Damage
2
2
Weakness
2
2
Air Embolism
2
2
Hypersensitivity/Allergic reaction
2
2
Inflammation
2
2
Nerve Damage
2
2
Infarction, Cerebral
2
2
Chest Pain
2
2
Purulent Discharge
1
1
Fever
1
1
Fistula
1
1
Angina
1
1
Vessel Or Plaque, Device Embedded In
1
1
Pulmonary Embolism
1
1
Syncope
1
1
Atrial Flutter
1
1
Itching Sensation
1
1
Muscle Weakness
1
1
Hypoxia
1
1
Hemorrhage, Cerebral
1
1
Great Vessel Perforation
1
1
Visual Disturbances
1
1
Sepsis
1
1
Rash
1
1
Abdominal Distention
1
1
Numbness
1
1
Coma
1
1
Loss of consciousness
1
1
Heart Failure
1
1
No Code Available
1
1
Cerebral Hyperperfusion Syndrome
1
1
Retroperitoneal Hemorrhage
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health Inc.
II
Dec-20-2019
2
Cordis Corporation
I
Mar-15-2021
3
Silk Road Medical Inc
II
Feb-23-2021
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