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
aortic valve, prosthesis, percutaneously delivered
Definition
To replace a patient's aortic heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.
Product Code
NPT
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
59
48
42
41
49
12
MDR Year
MDR Reports
MDR Events
2019
4361
9090
2020
5806
16016
2021
5605
22452
2022
5994
27660
2023
8321
29536
2024
2900
8682
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
14001
48667
Insufficient Information
3843
49029
Perivalvular Leak
3420
3628
Device Dislodged or Dislocated
2887
3236
Patient Device Interaction Problem
2158
3380
Malposition of Device
1264
1264
Gradient Increase
1051
1051
Fluid/Blood Leak
1030
1043
Burst Container or Vessel
993
993
Difficult to Remove
947
947
Degraded
940
940
Calcified
767
767
Material Split, Cut or Torn
705
705
Material Deformation
658
658
Migration or Expulsion of Device
627
1074
Difficult or Delayed Positioning
597
597
Material Invagination
592
592
Material Separation
527
527
Activation Failure
506
506
Difficult to Advance
450
450
Material Rupture
446
446
Migration
445
492
Difficult to Open or Close
388
388
Central Regurgitation
361
361
Appropriate Term/Code Not Available
335
369
Physical Resistance/Sticking
317
317
Failure to Advance
299
299
Device Stenosis
298
298
Material Twisted/Bent
267
267
Positioning Problem
243
469
Detachment of Device or Device Component
240
240
Inadequacy of Device Shape and/or Size
227
227
Incomplete Coaptation
196
196
Inflation Problem
173
173
Difficult to Insert
168
168
Improper or Incorrect Procedure or Method
164
164
Leak/Splash
142
142
Peeled/Delaminated
138
138
No Apparent Adverse Event
120
120
Break
113
113
Structural Problem
110
110
Activation, Positioning or Separation Problem
101
101
Patient-Device Incompatibility
99
101
Deformation Due to Compressive Stress
91
91
Difficult or Delayed Activation
85
85
Unintended Movement
84
84
Fracture
82
82
Material Puncture/Hole
75
75
Failure to Align
75
75
Difficult to Fold, Unfold or Collapse
74
74
Activation Problem
71
71
Backflow
69
69
Obstruction of Flow
69
80
Use of Device Problem
68
68
Thickening of Material
67
67
Entrapment of Device
64
64
Particulates
63
63
Retraction Problem
59
59
Positioning Failure
58
64
Device Damaged by Another Device
57
57
Material Integrity Problem
57
57
Material Protrusion/Extrusion
54
54
Material Fragmentation
50
50
Deflation Problem
50
50
Inaccurate Delivery
44
44
Mechanical Problem
43
46
Therapeutic or Diagnostic Output Failure
42
42
Separation Problem
37
37
Off-Label Use
34
34
Device Slipped
34
34
Device Difficult to Setup or Prepare
31
31
Contamination /Decontamination Problem
26
26
Failure to Conduct
21
165
Mechanical Jam
20
20
Defective Device
18
18
Device-Device Incompatibility
17
17
Device Markings/Labelling Problem
16
16
Loss of or Failure to Bond
16
16
Pacing Problem
16
142
Unintended Collision
14
14
Reflux within Device
13
13
Nonstandard Device
12
12
Crack
12
12
Coagulation in Device or Device Ingredient
11
31
Complete Blockage
10
10
Contamination
9
9
Device Contamination with Chemical or Other Material
9
9
Mechanics Altered
9
9
Device Contaminated During Manufacture or Shipping
8
8
Separation Failure
8
8
Material Perforation
8
8
Partial Blockage
8
8
Incorrect, Inadequate or Imprecise Result or Readings
8
8
Component Missing
7
7
Stretched
7
7
Tear, Rip or Hole in Device Packaging
7
7
Misassembly by Users
7
7
Device Handling Problem
6
6
Inaccurate Information
6
6
Microbial Contamination of Device
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4073
4073
Heart Block
3761
21111
Insufficient Information
3612
11403
Non specific EKG/ECG Changes
3022
7893
Stroke/CVA
2483
7306
Complete Heart Block
1579
1580
Valvular Insufficiency/ Regurgitation
1577
1773
Vascular Dissection
1475
2996
Hemorrhage/Bleeding
1380
5000
No Known Impact Or Consequence To Patient
1307
1320
Low Blood Pressure/ Hypotension
1166
1166
Aortic Valve Insufficiency/ Regurgitation
1155
2376
Arrhythmia
1154
7592
Injury
1150
4478
Rupture
1144
1371
Heart Failure/Congestive Heart Failure
1039
1424
Obstruction/Occlusion
990
1999
Death
967
2416
No Consequences Or Impact To Patient
966
966
Dyspnea
961
963
Aortic Regurgitation
785
813
Myocardial Infarction
765
2525
Aortic Valve Stenosis
720
733
Cardiac Arrest
716
3554
Atrial Fibrillation
571
1015
Blood Loss
562
717
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
559
7745
Thrombosis/Thrombus
517
1330
Calcium Deposits/Calcification
495
495
Cardiac Tamponade
472
580
Pericardial Effusion
464
464
Endocarditis
444
1107
Insufficiency, Valvular
407
407
No Code Available
407
511
Cardiac Perforation
381
2067
Bradycardia
373
373
Foreign Body In Patient
365
366
Vascular System (Circulation), Impaired
332
1413
Infarction, Cerebral
315
693
Stenosis
299
299
Cardiovascular Insufficiency
284
5746
Perforation of Vessels
279
344
Transient Ischemic Attack
265
1300
Perforation
263
844
Renal Failure
257
706
Occlusion
254
259
Hematoma
239
943
Aortic Dissection
211
258
Ventricular Fibrillation
208
208
Unspecified Infection
207
698
Unspecified Vascular Problem
195
1337
Chest Pain
194
194
No Information
191
4699
Ischemia Stroke
177
3299
Tachycardia
175
175
Pseudoaneurysm
167
167
Aortic Insufficiency
159
164
Cardiogenic Shock
157
157
Thrombosis
154
186
Failure of Implant
144
144
Anemia
137
137
Mitral Valve Insufficiency/ Regurgitation
130
130
Fatigue
126
127
Paralysis
124
124
Ischemia
118
501
Intimal Dissection
114
114
Low Cardiac Output
108
108
High Blood Pressure/ Hypertension
102
102
Fever
101
101
Hemolysis
100
100
Muscle Weakness
100
100
Thrombus
99
101
Regurgitation
97
97
Thromboembolism
91
91
Mitral Regurgitation
90
90
Syncope/Fainting
90
90
Dizziness
87
87
No Patient Involvement
86
86
Foreign Body Embolism
86
86
Unspecified Tissue Injury
85
85
Heart Failure
84
84
Sepsis
83
83
Pleural Effusion
83
83
Pain
82
83
Congestive Heart Failure
80
80
Regurgitation, Valvular
80
80
Pulmonary Edema
77
77
Cusp Tear
72
72
Swelling/ Edema
72
72
Embolism/Embolus
68
68
Hemolytic Anemia
67
67
Cardiac Enzyme Elevation
66
66
Great Vessel Perforation
63
63
Dysphasia
60
60
Pneumonia
60
60
Embolism
58
58
Speech Disorder
57
57
Paresis
56
56
Pulmonary Dysfunction
55
643
Loss of consciousness
55
55
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
I
Jan-09-2021
2
Edwards Lifesciences, LLC
I
Aug-21-2019
3
Edwards Lifesciences, LLC
II
Feb-14-2019
4
Medtronic Heart Valves Division
II
Jul-09-2021
5
Medtronic Heart Valves Division
II
Dec-10-2020
-
-