Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
intracranial aneurysm flow diverter
Definition
Treatment of wide-necked and larger or giant intracranial aneurysms.
Product Code
OUT
Device Class
3
Premarket Approvals (PMA)
2018
2019
2020
2021
2022
2023
7
5
9
13
7
0
MDR Year
MDR Reports
MDR Events
2018
425
425
2019
527
527
2020
809
809
2021
850
850
2022
1118
1118
Device Problems
MDRs with this Device Problem
Events in those MDRs
Activation Failure
1957
1957
Adverse Event Without Identified Device or Use Problem
1026
1026
Physical Resistance/Sticking
519
519
Material Deformation
289
289
Break
230
230
Activation, Positioning or Separation Problem
140
140
Unintended Movement
121
121
Migration
112
112
Positioning Failure
72
72
Retraction Problem
60
60
Unintended Ejection
54
54
Premature Activation
52
52
No Apparent Adverse Event
43
43
Detachment of Device or Device Component
36
36
Difficult to Open or Close
31
31
Activation Problem
26
26
Difficult or Delayed Activation
26
26
Difficult to Remove
24
24
Material Twisted/Bent
20
20
Positioning Problem
20
20
Migration or Expulsion of Device
19
19
Fracture
18
18
Physical Resistance
12
12
Device Dislodged or Dislocated
12
12
Appropriate Term/Code Not Available
9
9
Premature Separation
9
9
Malposition of Device
8
8
Deformation Due to Compressive Stress
7
7
Component or Accessory Incompatibility
5
5
Insufficient Information
4
4
Patient-Device Incompatibility
4
4
Component Missing
4
4
Difficult To Position
4
4
Material Separation
3
3
Obstruction of Flow
3
3
Mechanical Jam
3
3
Difficult or Delayed Separation
3
3
Packaging Problem
2
2
Stretched
2
2
Separation Failure
2
2
Material Frayed
2
2
Difficult to Fold, Unfold or Collapse
2
2
Mechanical Problem
2
2
Incorrect Measurement
1
1
Nonstandard Device
1
1
Unsealed Device Packaging
1
1
Material Fragmentation
1
1
Fluid/Blood Leak
1
1
Entrapment of Device
1
1
Collapse
1
1
Solder Joint Fracture
1
1
Defective Device
1
1
Improper or Incorrect Procedure or Method
1
1
Material Perforation
1
1
High Readings
1
1
Structural Problem
1
1
Failure to Advance
1
1
Therapeutic or Diagnostic Output Failure
1
1
No Flow
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1457
1457
No Known Impact Or Consequence To Patient
967
967
Thrombosis/Thrombus
222
222
Stenosis
188
188
Intracranial Hemorrhage
184
184
Stroke/CVA
156
156
Death
101
101
Thrombosis
92
92
Obstruction/Occlusion
86
86
Headache
86
86
Therapeutic Response, Decreased
81
81
Neurological Deficit/Dysfunction
75
75
Muscle Weakness
60
60
Hemorrhage/Bleeding
59
59
Paresis
59
59
No Consequences Or Impact To Patient
58
58
Thromboembolism
57
57
Ischemia
54
54
Infarction, Cerebral
52
52
Unspecified Nervous System Problem
52
52
Ischemia Stroke
48
48
Visual Disturbances
47
47
Paralysis
47
47
Transient Ischemic Attack
45
45
Vasoconstriction
44
44
Insufficient Information
42
42
Rupture
40
40
Fistula
39
39
Dysphasia
38
38
Occlusion
37
37
Hematoma
36
36
Aneurysm
34
34
Hemorrhage, Subarachnoid
34
34
Vascular Dissection
32
32
Loss of Vision
30
30
Thrombus
29
29
Swelling/ Edema
29
29
Visual Impairment
27
27
Foreign Body In Patient
25
25
Device Embedded In Tissue or Plaque
24
24
Speech Disorder
23
23
Hydrocephalus
22
22
Hemorrhage, Cerebral
22
22
Nausea
19
19
Blurred Vision
19
19
Perforation of Vessels
18
18
Pain
16
16
Ruptured Aneurysm
16
16
Perforation
14
14
Pseudoaneurysm
14
14
Convulsion/Seizure
12
12
Embolus
12
12
Cognitive Changes
11
11
Embolism/Embolus
11
11
Loss of consciousness
10
10
Therapeutic Effects, Unexpected
10
10
Dizziness
10
10
High Blood Pressure/ Hypertension
9
9
Low Blood Pressure/ Hypotension
9
9
Discomfort
8
8
Numbness
8
8
Syncope/Fainting
8
8
Cerebral Edema
8
8
Confusion/ Disorientation
7
7
Brain Injury
7
7
Nerve Damage
7
7
Edema
7
7
Bradycardia
6
6
Hypersensitivity/Allergic reaction
6
6
Neuropathy
6
6
Unspecified Infection
6
6
Memory Loss/Impairment
6
6
Dyskinesia
6
6
Tachycardia
6
6
Seizures
6
6
No Information
6
6
Shaking/Tremors
5
5
Hyperplasia
5
5
No Patient Involvement
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Renal Failure
4
4
Cardiac Arrest
4
4
Arrhythmia
4
4
Foreign Body Reaction
4
4
No Code Available
4
4
Hemorrhagic Stroke
4
4
Movement Disorder
3
3
Paraplegia
3
3
Lethargy
3
3
Granuloma
3
3
Fatigue
3
3
Feeding Problem
3
3
Emotional Changes
3
3
Dysphagia/ Odynophagia
3
3
Pulmonary Embolism
3
3
Anemia
3
3
Coagulation Disorder
3
3
Bacterial Infection
3
3
Hemorrhage, Intraventricular
3
3
Eye Pain
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Micro Therapeutics Inc,
I
Sep-03-2021
2
Micro Therapeutics Inc, Dba Ev3 Neurovascular
I
Mar-09-2020
-
-