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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)
2018
2019
2020
2021
2022
2023
12
11
7
13
17
14
MDR Year
MDR Reports
MDR Events
2018
103
103
2019
181
181
2020
163
163
2021
201
201
2022
172
172
2023
162
162
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
295
295
Activation, Positioning or Separation Problem
112
112
Difficult or Delayed Positioning
101
101
Material Deformation
73
73
Difficult to Advance
55
55
Activation Failure
52
52
Difficult to Remove
52
52
Material Separation
47
47
Premature Activation
47
47
Detachment of Device or Device Component
47
47
Break
46
46
Positioning Failure
40
40
Fracture
27
27
Entrapment of Device
21
21
Failure to Advance
21
21
Malposition of Device
18
18
Mechanical Jam
18
18
Mechanical Problem
16
16
Migration
13
13
Material Split, Cut or Torn
11
11
Positioning Problem
11
11
Defective Device
10
10
Device Dislodged or Dislocated
10
10
Deformation Due to Compressive Stress
10
10
Physical Resistance/Sticking
10
10
Device Contamination with Chemical or Other Material
8
8
Material Integrity Problem
8
8
Migration or Expulsion of Device
8
8
Material Frayed
8
8
Difficult to Insert
8
8
Device Damaged by Another Device
7
7
Patient-Device Incompatibility
6
6
Difficult or Delayed Activation
6
6
Detachment Of Device Component
6
6
Crack
6
6
Improper or Incorrect Procedure or Method
6
6
Retraction Problem
5
5
Off-Label Use
5
5
Unsealed Device Packaging
4
4
Use of Device Problem
4
4
Loss of or Failure to Bond
4
4
Leak/Splash
4
4
Obstruction of Flow
4
4
Device-Device Incompatibility
4
4
Tear, Rip or Hole in Device Packaging
3
3
Material Twisted/Bent
3
3
Difficult to Open or Remove Packaging Material
3
3
Therapeutic or Diagnostic Output Failure
2
2
Component Missing
2
2
Device Markings/Labelling Problem
2
2
Loose or Intermittent Connection
2
2
Bent
2
2
Contamination
2
2
Device Damaged Prior to Use
2
2
Device Difficult to Setup or Prepare
2
2
Difficult to Flush
2
2
Activation Problem
2
2
Poor Visibility
1
1
Material Too Soft/Flexible
1
1
Occlusion Within Device
1
1
Material Puncture/Hole
1
1
Defective Component
1
1
Stretched
1
1
Failure to Capture
1
1
Collapse
1
1
Partial Blockage
1
1
Accessory Incompatible
1
1
Device Expiration Issue
1
1
Device Operates Differently Than Expected
1
1
Capturing Problem
1
1
Inaccurate Delivery
1
1
Ambient Temperature Problem
1
1
Torn Material
1
1
Insufficient Information
1
1
Patient Device Interaction 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
333
333
No Consequences Or Impact To Patient
239
239
Stroke/CVA
95
95
Thrombosis/Thrombus
82
82
Ischemia Stroke
49
49
Patient Problem/Medical Problem
42
42
Transient Ischemic Attack
39
39
Stenosis
36
36
Thrombosis
31
31
Vascular Dissection
30
30
Myocardial Infarction
29
29
No Patient Involvement
25
25
Obstruction/Occlusion
24
24
Low Blood Pressure/ Hypotension
22
22
Restenosis
21
21
Occlusion
18
18
Brain Injury
17
17
Bradycardia
17
17
No Known Impact Or Consequence To Patient
16
16
Insufficient Information
15
15
Hematoma
15
15
Thrombus
14
14
Foreign Body In Patient
14
14
Pain
12
12
Embolism
11
11
Intracranial Hemorrhage
10
10
Death
10
10
Hemorrhage/Bleeding
9
9
Unspecified Tissue Injury
9
9
Blood Loss
8
8
Renal Failure
7
7
Device Embedded In Tissue or Plaque
7
7
Embolism/Embolus
6
6
High Blood Pressure/ Hypertension
6
6
Arrhythmia
6
6
Paresis
5
5
Seizures
5
5
Vasoconstriction
5
5
Dizziness
5
5
Perforation of Vessels
4
4
Neurological Deficit/Dysfunction
4
4
Reocclusion
4
4
Extravasation
4
4
Cardiac Arrest
4
4
Headache
4
4
Ischemia
4
4
Unspecified Infection
3
3
Hemorrhage, Cerebral
3
3
Infarction, Cerebral
3
3
Aneurysm
3
3
Perforation
3
3
Paralysis
3
3
Dysphasia
3
3
Weakness
3
3
Neck Pain
3
3
Prolapse
3
3
Injury
3
3
Hemorrhagic Stroke
3
3
Unspecified Nervous System Problem
3
3
Convulsion/Seizure
3
3
Nervous System Injury
3
3
Rupture
3
3
Pseudoaneurysm
3
3
Thromboembolism
2
2
No Information
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Swelling/ Edema
2
2
Visual Impairment
2
2
Loss of Vision
2
2
Tissue Damage
2
2
Intimal Dissection
2
2
Pulmonary Embolism
2
2
Syncope
2
2
Air Embolism
2
2
Chest Pain
2
2
Hypersensitivity/Allergic reaction
2
2
Inflammation
2
2
Nerve Damage
2
2
Itching Sensation
1
1
Muscle Weakness
1
1
Hypoxia
1
1
Vessel Or Plaque, Device Embedded In
1
1
Purulent Discharge
1
1
Fever
1
1
Fistula
1
1
Angina
1
1
Atrial Flutter
1
1
Sepsis
1
1
Visual Disturbances
1
1
Rash
1
1
Numbness
1
1
Coma
1
1
Loss of consciousness
1
1
Abdominal Distention
1
1
Great Vessel Perforation
1
1
Convulsion, Clonic
1
1
Heart Failure
1
1
Retroperitoneal Hemorrhage
1
1
Cramp(s) /Muscle Spasm(s)
1
1
No Code Available
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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