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TPLC
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Device
replacement heart-valve
Regulation Description
Replacement heart valve.
Definition
Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))
Product Code
DYE
Regulation Number
870.3925
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
13
7
8
11
7
6
MDR Year
MDR Reports
MDR Events
2020
2466
2466
2021
2833
2833
2022
2566
2566
2023
3494
3494
2024
3452
3452
2025
1473
1473
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
6821
6821
Gradient Increase
5443
5443
Degraded
2383
2383
Fluid/Blood Leak
2379
2379
Calcified
2002
2002
Device Stenosis
1873
1873
Adverse Event Without Identified Device or Use Problem
964
964
Patient Device Interaction Problem
960
960
Central Regurgitation
763
763
Difficult to Open or Close
568
568
Appropriate Term/Code Not Available
482
482
Perivalvular Leak
427
427
Incomplete Coaptation
306
306
Material Split, Cut or Torn
188
188
Inadequacy of Device Shape and/or Size
132
132
Thickening of Material
104
104
Patient-Device Incompatibility
84
84
Structural Problem
83
83
Detachment of Device or Device Component
76
76
Break
59
59
Therapeutic or Diagnostic Output Failure
51
51
Mechanical Jam
50
50
Entrapment of Device
36
36
Obstruction of Flow
26
26
Microbial Contamination of Device
20
20
Off-Label Use
15
15
Device Dislodged or Dislocated
15
15
Leak/Splash
14
14
Material Separation
14
14
Material Integrity Problem
13
13
Unintended Movement
11
11
Fracture
10
10
Partial Blockage
10
10
Contamination /Decontamination Problem
10
10
Backflow
9
9
Malposition of Device
9
9
Material Puncture/Hole
9
9
Material Perforation
8
8
Material Deformation
8
8
Mechanical Problem
7
7
Pitted
7
7
Material Too Rigid or Stiff
6
6
Naturally Worn
6
6
Material Twisted/Bent
6
6
Separation Problem
5
5
Unsealed Device Packaging
5
5
Reflux within Device
5
5
Particulates
5
5
Packaging Problem
5
5
Contamination
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
8301
8301
Heart Failure/Congestive Heart Failure
2845
2845
Dyspnea
2613
2613
Aortic Valve Stenosis
2327
2327
Aortic Valve Insufficiency/ Regurgitation
1232
1232
Mitral Valve Stenosis
572
572
Aortic Regurgitation
461
461
Fatigue
442
442
Endocarditis
437
437
Stenosis
346
346
Chest Pain
315
315
Mitral Regurgitation
310
310
No Clinical Signs, Symptoms or Conditions
305
305
No Known Impact Or Consequence To Patient
255
255
Regurgitation
242
242
No Information
238
238
Calcium Deposits/Calcification
213
213
Non specific EKG/ECG Changes
178
178
Mitral Valve Insufficiency/ Regurgitation
169
169
Dizziness
156
156
Syncope/Fainting
141
141
Pulmonary Valve Stenosis
136
136
Congestive Heart Failure
135
135
Heart Block
112
112
Thrombosis/Thrombus
111
111
Atrial Fibrillation
109
109
Aortic Insufficiency
106
106
Cardiogenic Shock
105
105
Swelling/ Edema
99
99
Cusp Tear
88
88
Hemorrhage/Bleeding
85
85
Valvular Insufficiency/ Regurgitation
85
85
No Code Available
83
83
Pulmonary Regurgitation
75
75
Stroke/CVA
74
74
Failure of Implant
73
73
Tricuspid Valve Stenosis
63
63
Death
55
55
Pulmonary Valve Insufficiency/ Regurgitation
42
42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
42
42
Tachycardia
41
41
Corneal Pannus
41
41
Cardiac Arrest
40
41
Obstruction/Occlusion
37
37
Tricuspid Regurgitation
35
35
Unspecified Infection
34
34
Low Blood Pressure/ Hypotension
33
33
Bradycardia
33
33
Cardiomyopathy
32
32
Thrombosis
31
31
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