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TPLC
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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)
2020
2021
2022
2023
2024
2025
9
13
7
8
14
5
MDR Year
MDR Reports
MDR Events
2020
809
809
2021
850
850
2022
1118
1118
2023
1186
1186
2024
1327
1327
2025
858
858
Device Problems
MDRs with this Device Problem
Events in those MDRs
Activation Failure
3253
3253
Adverse Event Without Identified Device or Use Problem
1595
1595
Physical Resistance/Sticking
1064
1064
Material Deformation
817
817
Activation, Positioning or Separation Problem
366
366
Unintended Movement
310
310
Retraction Problem
243
243
Break
210
210
Migration
184
184
Positioning Failure
138
138
Unintended Ejection
119
119
Structural Problem
111
111
Material Frayed
99
99
Material Twisted/Bent
98
98
Premature Activation
94
94
Deformation Due to Compressive Stress
93
93
No Apparent Adverse Event
81
81
Difficult to Remove
62
62
Device Dislodged or Dislocated
53
53
Improper or Incorrect Procedure or Method
42
42
Malposition of Device
42
42
Material Separation
40
40
Activation Problem
36
36
Detachment of Device or Device Component
34
34
Fracture
33
33
Collapse
30
30
Difficult or Delayed Activation
27
27
Difficult to Open or Close
26
26
Premature Separation
22
22
Difficult or Delayed Positioning
20
20
Use of Device Problem
16
16
Lack of Effect
15
15
Stretched
10
10
Device Damaged by Another Device
8
8
Entrapment of Device
8
8
Appropriate Term/Code Not Available
8
8
Component or Accessory Incompatibility
7
7
Difficult or Delayed Separation
7
7
Component Missing
6
6
Insufficient Information
6
6
Packaging Problem
6
6
Patient-Device Incompatibility
6
6
Migration or Expulsion of Device
6
6
Positioning Problem
5
5
Material Integrity Problem
5
5
Difficult to Fold, Unfold or Collapse
4
4
Off-Label Use
4
4
Display or Visual Feedback Problem
3
3
Separation Failure
3
3
Device Stenosis
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3754
3754
Thrombosis/Thrombus
450
450
Stenosis
388
388
No Known Impact Or Consequence To Patient
361
361
Intracranial Hemorrhage
252
252
Stroke/CVA
231
231
Obstruction/Occlusion
229
229
Ischemia Stroke
213
213
Headache
199
199
Aneurysm
170
170
Unspecified Nervous System Problem
128
128
Hemorrhage/Bleeding
123
123
Muscle Weakness
113
113
Failure of Implant
110
110
Paresis
107
107
Visual Disturbances
100
100
Vasoconstriction
98
98
Insufficient Information
89
89
Ischemia
87
87
Paralysis
85
85
Transient Ischemic Attack
78
78
Dysphasia
76
76
Thromboembolism
72
72
Rupture
67
67
Hematoma
63
63
Vascular Dissection
61
61
Death
54
54
Swelling/ Edema
53
53
Ruptured Aneurysm
50
50
Speech Disorder
49
49
Hemorrhagic Stroke
49
49
Foreign Body In Patient
47
47
Blurred Vision
45
45
Visual Impairment
45
45
Numbness
43
43
Dizziness
42
42
Cognitive Changes
42
42
Loss of Vision
41
41
Fistula
38
38
Nausea
36
36
Hyperplasia
36
36
Pain
34
34
Hydrocephalus
33
33
Nervous System Injury
29
29
Therapeutic Response, Decreased
28
28
Pseudoaneurysm
26
26
Perforation of Vessels
26
26
Convulsion/Seizure
25
25
Cerebral Edema
25
25
Thrombosis
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
4
Micro Therapeutics, Inc.
I
Mar-05-2025
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