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TPLC
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show TPLC since
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Device
heart-valve, mechanical
Product Code
LWQ
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
6
9
8
9
6
0
MDR Year
MDR Reports
MDR Events
2020
372
372
2021
287
287
2022
297
297
2023
455
455
2024
406
406
2025
29
29
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
567
567
Insufficient Information
410
410
Physical Resistance/Sticking
151
151
Incomplete Coaptation
150
150
Perivalvular Leak
114
114
Patient Device Interaction Problem
113
113
Fracture
86
86
Detachment of Device or Device Component
72
72
Biocompatibility
70
70
Inadequacy of Device Shape and/or Size
52
52
Material Separation
48
48
Obstruction of Flow
47
47
Difficult to Open or Close
44
44
Patient-Device Incompatibility
36
36
Gradient Increase
31
31
Device Stenosis
29
29
Backflow
26
26
Central Regurgitation
25
25
Improper or Incorrect Procedure or Method
14
14
Appropriate Term/Code Not Available
13
13
Device Dislodged or Dislocated
12
12
Mechanical Jam
11
11
Break
11
11
Off-Label Use
11
11
Degraded
7
7
Material Integrity Problem
7
7
Device Markings/Labelling Problem
6
6
No Apparent Adverse Event
6
6
Material Split, Cut or Torn
5
5
Use of Device Problem
5
5
Device Damaged by Another Device
4
4
Contamination /Decontamination Problem
4
4
Migration or Expulsion of Device
4
4
Packaging Problem
3
3
Leak/Splash
3
3
Crack
3
3
Unsealed Device Packaging
3
3
Product Quality Problem
3
3
Material Frayed
2
2
Calcified
2
2
Mechanical Problem
2
2
Human-Device Interface Problem
2
2
Malposition of Device
1
1
Partial Blockage
1
1
Microbial Contamination of Device
1
1
Expiration Date Error
1
1
Thickening of Material
1
1
Material Deformation
1
1
Material Puncture/Hole
1
1
Burst Container or Vessel
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
414
414
No Clinical Signs, Symptoms or Conditions
310
310
Hemorrhage/Bleeding
131
131
Endocarditis
122
122
Stroke/CVA
122
122
Thrombosis/Thrombus
122
122
No Information
98
98
Aortic Valve Insufficiency/ Regurgitation
81
81
Heart Failure/Congestive Heart Failure
78
78
Dyspnea
77
77
Atrial Fibrillation
76
76
Heart Block
57
57
Aortic Valve Stenosis
55
55
Death
54
54
Valvular Insufficiency/ Regurgitation
51
51
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
42
42
Mitral Valve Insufficiency/ Regurgitation
42
42
Non specific EKG/ECG Changes
41
41
Thromboembolism
37
37
Arrhythmia
35
35
Renal Failure
34
34
Unspecified Infection
32
32
Pericardial Effusion
30
30
Obstruction/Occlusion
29
29
Pseudoaneurysm
29
29
Anemia
28
28
No Known Impact Or Consequence To Patient
28
28
Myocardial Infarction
27
27
Cardiac Arrest
27
27
No Consequences Or Impact To Patient
27
27
Thrombus
26
26
Tachycardia
25
25
Pleural Effusion
22
22
Mitral Valve Stenosis
21
21
Hematoma
19
19
Transient Ischemic Attack
19
19
Cardiac Tamponade
18
18
Hemolytic Anemia
17
17
Chest Pain
17
17
Hemolysis
16
16
Sepsis
16
16
Low Blood Pressure/ Hypotension
15
15
Cardiogenic Shock
15
15
Thrombosis
15
15
Low Cardiac Output
14
14
High Blood Pressure/ Hypertension
14
14
Ventricular Fibrillation
14
14
Respiratory Insufficiency
14
14
Pulmonary Edema
13
13
Mitral Regurgitation
12
12
Recalls
Manufacturer
Recall Class
Date Posted
1
MEDTRONIC ATS MEDICAL, INC.
II
Mar-20-2020
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