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TPLC
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show TPLC since
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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
12
MDR Year
MDR Reports
MDR Events
2019
527
527
2020
809
809
2021
850
850
2022
1118
1118
2023
1186
1186
2024
853
853
Device Problems
MDRs with this Device Problem
Events in those MDRs
Activation Failure
2855
2855
Adverse Event Without Identified Device or Use Problem
1429
1429
Physical Resistance/Sticking
828
828
Material Deformation
569
569
Break
244
244
Activation, Positioning or Separation Problem
228
228
Unintended Movement
220
220
Migration
161
161
Retraction Problem
110
110
Positioning Failure
107
107
Unintended Ejection
87
87
No Apparent Adverse Event
74
74
Premature Activation
73
73
Material Twisted/Bent
58
58
Difficult to Remove
49
49
Deformation Due to Compressive Stress
48
48
Material Frayed
44
44
Structural Problem
40
40
Detachment of Device or Device Component
39
39
Activation Problem
36
36
Difficult or Delayed Activation
34
34
Malposition of Device
32
32
Fracture
31
31
Improper or Incorrect Procedure or Method
28
28
Material Separation
28
28
Device Dislodged or Dislocated
28
28
Premature Separation
22
22
Difficult or Delayed Positioning
15
15
Collapse
12
12
Difficult to Open or Close
11
11
Positioning Problem
11
11
Lack of Effect
10
10
Stretched
9
9
Appropriate Term/Code Not Available
9
9
Component or Accessory Incompatibility
8
8
Difficult or Delayed Separation
7
7
Insufficient Information
6
6
Migration or Expulsion of Device
5
5
Patient-Device Incompatibility
5
5
Component Missing
5
5
Entrapment of Device
4
4
Off-Label Use
4
4
Use of Device Problem
4
4
Packaging Problem
3
3
Material Integrity Problem
3
3
Device Damaged by Another Device
3
3
Separation Failure
2
2
Difficult to Fold, Unfold or Collapse
2
2
Obstruction of Flow
2
2
Flushing Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2817
2817
No Known Impact Or Consequence To Patient
707
707
Thrombosis/Thrombus
363
363
Stenosis
307
307
Intracranial Hemorrhage
242
242
Stroke/CVA
220
220
Obstruction/Occlusion
182
182
Headache
158
158
Ischemia Stroke
134
134
Unspecified Nervous System Problem
112
112
Aneurysm
109
109
Hemorrhage/Bleeding
103
103
Muscle Weakness
94
94
Paresis
94
94
Ischemia
90
90
Vasoconstriction
85
85
Visual Disturbances
82
82
Death
79
79
Insufficient Information
79
79
Transient Ischemic Attack
70
70
Paralysis
69
69
Thromboembolism
69
69
Failure of Implant
66
66
Dysphasia
66
66
Rupture
65
65
Therapeutic Response, Decreased
57
57
Vascular Dissection
55
55
Hematoma
53
53
No Consequences Or Impact To Patient
50
50
Foreign Body In Patient
45
45
Thrombosis
45
45
Fistula
44
44
Neurological Deficit/Dysfunction
44
44
Speech Disorder
41
41
Swelling/ Edema
41
41
Visual Impairment
41
41
Blurred Vision
39
39
Loss of Vision
39
39
Infarction, Cerebral
34
34
Ruptured Aneurysm
33
33
Hydrocephalus
31
31
Cognitive Changes
31
31
Nausea
30
30
Hemorrhagic Stroke
27
27
Pain
27
27
Perforation of Vessels
26
26
Hemorrhage, Subarachnoid
25
25
Numbness
25
25
Device Embedded In Tissue or Plaque
25
25
Thrombus
24
24
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
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