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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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)
2019
2020
2021
2022
2023
2024
5
9
13
7
8
2
MDR Year
MDR Reports
MDR Events
2019
527
527
2020
809
809
2021
850
850
2022
1118
1118
2023
1186
1186
2024
310
310
Device Problems
MDRs with this Device Problem
Events in those MDRs
Activation Failure
2535
2535
Adverse Event Without Identified Device or Use Problem
1301
1301
Physical Resistance/Sticking
725
725
Material Deformation
479
479
Break
231
231
Activation, Positioning or Separation Problem
195
195
Unintended Movement
189
189
Migration
143
143
Positioning Failure
96
96
Retraction Problem
77
77
Unintended Ejection
71
71
Premature Activation
67
67
No Apparent Adverse Event
65
65
Material Twisted/Bent
43
43
Detachment of Device or Device Component
39
39
Difficult to Remove
39
39
Difficult or Delayed Activation
31
31
Deformation Due to Compressive Stress
31
31
Activation Problem
30
30
Fracture
29
29
Improper or Incorrect Procedure or Method
23
23
Material Frayed
22
22
Malposition of Device
21
21
Material Separation
19
19
Premature Separation
19
19
Structural Problem
18
18
Difficult or Delayed Positioning
13
13
Device Dislodged or Dislocated
13
13
Positioning Problem
10
10
Difficult to Open or Close
10
10
Component or Accessory Incompatibility
8
8
Appropriate Term/Code Not Available
7
7
Insufficient Information
5
5
Component Missing
5
5
Migration or Expulsion of Device
5
5
Patient-Device Incompatibility
4
4
Difficult or Delayed Separation
4
4
Lack of Effect
3
3
Device Damaged by Another Device
3
3
Off-Label Use
3
3
Flushing Problem
2
2
Difficult to Fold, Unfold or Collapse
2
2
Entrapment of Device
2
2
Collapse
2
2
Obstruction of Flow
2
2
Separation Failure
2
2
Packaging Problem
2
2
Material Integrity Problem
2
2
No Flow
1
1
Therapeutic or Diagnostic Output Failure
1
1
Difficult to Advance
1
1
Device Contaminated During Manufacture or Shipping
1
1
Device Stenosis
1
1
Extra Components
1
1
Separation Problem
1
1
Failure to Advance
1
1
Defective Device
1
1
Solder Joint Fracture
1
1
Material Perforation
1
1
Stretched
1
1
Fluid/Blood Leak
1
1
Nonstandard Device
1
1
Unsealed Device Packaging
1
1
Difficult to Insert
1
1
Material Fragmentation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2439
2439
No Known Impact Or Consequence To Patient
707
707
Thrombosis/Thrombus
339
339
Stenosis
278
278
Intracranial Hemorrhage
222
222
Stroke/CVA
213
213
Obstruction/Occlusion
153
153
Headache
143
143
Ischemia Stroke
106
106
Unspecified Nervous System Problem
98
98
Hemorrhage/Bleeding
86
86
Paresis
85
85
Muscle Weakness
82
82
Aneurysm
81
81
Death
79
79
Ischemia
79
79
Insufficient Information
74
74
Vasoconstriction
72
72
Visual Disturbances
71
71
Paralysis
66
66
Thromboembolism
66
66
Transient Ischemic Attack
62
62
Rupture
62
62
Therapeutic Response, Decreased
57
57
Dysphasia
55
55
No Consequences Or Impact To Patient
50
50
Hematoma
47
47
Thrombosis
45
45
Neurological Deficit/Dysfunction
44
44
Vascular Dissection
44
44
Fistula
42
42
Swelling/ Edema
40
40
Foreign Body In Patient
39
39
Visual Impairment
38
38
Loss of Vision
37
37
Speech Disorder
37
37
Blurred Vision
35
35
Infarction, Cerebral
34
34
Failure of Implant
30
30
Nausea
29
29
Hydrocephalus
28
28
Ruptured Aneurysm
28
28
Pain
26
26
Cognitive Changes
25
25
Hemorrhage, Subarachnoid
25
25
Thrombus
24
24
Device Embedded In Tissue or Plaque
24
24
Perforation of Vessels
23
23
Dizziness
21
21
Occlusion
21
21
Hemorrhagic Stroke
21
21
Convulsion/Seizure
21
21
Numbness
20
20
Pseudoaneurysm
18
18
Hemorrhage, Cerebral
17
17
Memory Loss/Impairment
15
15
Confusion/ Disorientation
14
14
Embolism/Embolus
14
14
Syncope/Fainting
13
13
Nerve Damage
13
13
Low Blood Pressure/ Hypotension
12
12
Embolus
12
12
Cerebral Edema
12
12
Hyperplasia
11
11
Loss of consciousness
11
11
Therapeutic Effects, Unexpected
10
10
Eye Pain
9
9
Paresthesia
8
8
Movement Disorder
8
8
Perforation
8
8
Discomfort
8
8
Dyskinesia
8
8
Hypersensitivity/Allergic reaction
8
8
High Blood Pressure/ Hypertension
8
8
Neuropathy
8
8
Fatigue
8
8
Arrhythmia
7
7
Unspecified Infection
7
7
Tachycardia
7
7
Vomiting
7
7
Seizures
6
6
Anemia
6
6
Bradycardia
6
6
Edema
6
6
Foreign Body Reaction
5
5
Brain Injury
5
5
Shaking/Tremors
5
5
No Patient Involvement
5
5
Nervous System Injury
5
5
Ptosis
4
4
Coma
4
4
Renal Failure
4
4
Fever
4
4
Inflammation
4
4
Myocardial Infarction
4
4
Coagulation Disorder
4
4
Extravasation
4
4
Bacterial Infection
4
4
Aphonia
4
4
Cerebral Hyperperfusion Syndrome
4
4
Recalls
Manufacturer
Recall Class
Date Posted
1
MICROVENTION INC.
II
Jul-27-2023
2
Micro Therapeutics Inc,
I
Sep-03-2021
3
Micro Therapeutics Inc, Dba Ev3 Neurovascular
I
Mar-09-2020
-
-