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TPLC
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show TPLC since
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2014
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2024
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Device
heart-valve, non-allograft tissue
Product Code
LWR
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
15
17
25
18
31
27
14
27
54
64
50
32
18
37
26
10
MDR Year
MDR Reports
MDR Events
2014
365
365
2015
525
525
2016
736
736
2017
1367
1367
2018
1593
1593
2019
1855
1855
2020
1437
1437
2021
1550
1550
2022
1084
1084
2023
1593
1593
2024
381
381
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
4618
4618
Adverse Event Without Identified Device or Use Problem
1563
1563
Gradient Increase
1201
1201
Perivalvular Leak
961
961
Material Split, Cut or Torn
780
780
Calcified
759
759
Degraded
664
664
Obstruction of Flow
523
523
Incomplete Coaptation
492
492
Patient-Device Incompatibility
472
472
Inadequacy of Device Shape and/or Size
379
379
Backflow
378
378
Leak/Splash
337
337
Fluid/Blood Leak
294
294
Patient Device Interaction Problem
292
292
Torn Material
280
280
Central Regurgitation
269
269
Appropriate Term/Code Not Available
237
237
Device Stenosis
212
212
Material Deformation
194
194
Biocompatibility
151
151
Device Operates Differently Than Expected
138
138
Difficult to Open or Close
119
119
Material Too Rigid or Stiff
108
108
Detachment of Device or Device Component
88
88
Material Separation
82
82
Occlusion Within Device
82
82
Structural Problem
81
81
Device Dislodged or Dislocated
74
74
Microbial Contamination of Device
67
67
Malposition of Device
65
65
Collapse
63
63
Off-Label Use
55
55
Material Rupture
54
54
Material Perforation
49
49
Material Puncture/Hole
38
38
Difficult to Fold, Unfold or Collapse
37
37
No Apparent Adverse Event
33
33
Migration
30
30
Break
30
30
Material Integrity Problem
30
30
Material Distortion
28
28
Therapeutic or Diagnostic Output Failure
26
26
Partial Blockage
26
26
Hole In Material
24
24
Positioning Failure
24
24
Migration or Expulsion of Device
24
24
Use of Device Problem
24
24
Improper or Incorrect Procedure or Method
21
21
Infusion or Flow Problem
19
19
Missing Information
19
19
Material Twisted/Bent
17
17
Improper Flow or Infusion
15
15
Reflux within Device
15
15
Naturally Worn
14
14
Activation Failure
14
14
Positioning Problem
13
13
Folded
13
13
Kinked
13
13
Material Disintegration
13
13
Fracture
12
12
Difficult or Delayed Separation
11
11
Detachment Of Device Component
10
10
Stretched
9
9
Defective Device
9
9
Thickening of Material
9
9
Separation Problem
9
9
Unintended Movement
8
8
Mechanical Jam
6
6
Human-Device Interface Problem
6
6
Activation, Positioning or Separation Problem
6
6
Tear, Rip or Hole in Device Packaging
6
6
Contamination /Decontamination Problem
6
6
Loose or Intermittent Connection
6
6
Mechanical Problem
6
6
Entrapment of Device
6
6
Material Invagination
5
5
Crack
5
5
Product Quality Problem
5
5
Peeled/Delaminated
4
4
Nonstandard Device
4
4
Device Inoperable
4
4
Device Appears to Trigger Rejection
4
4
Complete Blockage
4
4
Material Discolored
4
4
Cut In Material
4
4
Defective Component
4
4
Expiration Date Error
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Scratched Material
4
4
Device Handling Problem
4
4
Physical Resistance/Sticking
3
3
Mechanics Altered
3
3
Gas/Air Leak
3
3
Device Contamination with Chemical or Other Material
3
3
Unstable
3
3
Device Damaged by Another Device
3
3
Material Erosion
3
3
Material Fragmentation
3
3
Material Frayed
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
1810
1810
Aortic Valve Stenosis
1769
1769
No Information
1692
1695
Aortic Regurgitation
1193
1193
Aortic Valve Insufficiency/ Regurgitation
1172
1172
Aortic Insufficiency
1087
1087
Endocarditis
916
916
Dyspnea
789
789
Death
610
610
Calcium Deposits/Calcification
525
525
No Known Impact Or Consequence To Patient
511
511
Heart Failure/Congestive Heart Failure
480
480
Complete Heart Block
369
369
No Clinical Signs, Symptoms or Conditions
318
318
Mitral Regurgitation
312
312
Hemorrhage/Bleeding
270
270
Stroke/CVA
267
267
Corneal Pannus
260
260
Stenosis
236
236
Cusp Tear
219
219
No Code Available
208
208
Pulmonary Valve Stenosis
199
200
Atrial Fibrillation
193
193
Mitral Valve Stenosis
183
184
Mitral Valve Insufficiency/ Regurgitation
181
181
Heart Failure
181
181
Arrhythmia
171
172
Thrombus
168
169
Non specific EKG/ECG Changes
155
155
Thrombosis/Thrombus
146
146
Heart Block
139
139
Fatigue
129
129
Unspecified Infection
129
129
Renal Failure
115
116
Congestive Heart Failure
112
112
Myocardial Infarction
108
108
Chest Pain
105
105
Regurgitation
104
104
Pseudoaneurysm
98
98
Pulmonary Regurgitation
98
98
Thrombosis
90
90
Blood Loss
88
89
Insufficiency, Valvular
84
84
Cardiac Arrest
81
81
Valvular Insufficiency/ Regurgitation
79
79
Mitral Insufficiency
78
79
Obstruction/Occlusion
76
76
No Consequences Or Impact To Patient
73
73
Regurgitation, Valvular
71
71
Pulmonary Edema
70
70
Cardiogenic Shock
67
67
Low Blood Pressure/ Hypotension
66
66
Bradycardia
66
66
Pleural Effusion
64
64
Sepsis
63
63
Rupture
62
62
Thromboembolism
62
62
Aneurysm
59
59
Fever
59
59
Tricuspid Regurgitation
57
57
Abscess
56
56
Cardiac Tamponade
55
55
Hematoma
54
54
High Blood Pressure/ Hypertension
51
51
Low Cardiac Output
50
50
Failure of Implant
47
48
Host-Tissue Reaction
45
45
Transient Ischemic Attack
42
42
Pulmonary Valve Insufficiency/ Regurgitation
42
42
Thrombocytopenia
39
39
Angina
39
39
Pulmonary Insufficiency
37
38
Hemolysis
35
35
Valvular Stenosis
35
35
Respiratory Failure
34
34
Prolapse
34
34
Ventricular Fibrillation
34
34
Pericardial Effusion
33
33
Tachycardia
31
32
Bacterial Infection
31
31
Ischemia
30
30
Tricuspid Valve Stenosis
28
28
Foreign Body Reaction
28
28
Edema
27
27
Pneumonia
27
27
Perforation
26
26
Vascular Dissection
26
26
Laceration(s)
25
25
Multiple Organ Failure
24
24
Injury
24
24
Dizziness
23
23
Vascular System (Circulation), Impaired
23
23
Infarction, Cerebral
23
23
Anemia
23
23
Embolism
22
22
Hemolytic Anemia
22
22
Aortic Dissection
22
22
Cardiac Perforation
21
21
Occlusion
21
21
Syncope
20
20
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Cardiovascular Surgery-the Heart Valve Division
II
Feb-03-2014
2
Sorin Group Italia S.r.l.
II
Sep-18-2020
3
Sorin Group USA, Inc.
II
Dec-07-2016
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