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TPLC
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Device
heart-valve, non-allograft tissue
Product Code
LWR
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
32
18
37
26
27
2
MDR Year
MDR Reports
MDR Events
2020
1437
1437
2021
1550
1550
2022
1084
1084
2023
1593
1593
2024
1815
1821
2025
139
139
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
2769
2769
Adverse Event Without Identified Device or Use Problem
825
828
Degraded
647
647
Gradient Increase
597
597
Central Regurgitation
573
576
Material Split, Cut or Torn
572
572
Calcified
548
548
Perivalvular Leak
541
541
Device Stenosis
499
502
Patient Device Interaction Problem
483
483
Backflow
361
361
Incomplete Coaptation
314
314
Patient-Device Incompatibility
302
302
Fluid/Blood Leak
301
301
Obstruction of Flow
274
274
Inadequacy of Device Shape and/or Size
222
222
Biocompatibility
122
122
Difficult to Open or Close
119
119
Detachment of Device or Device Component
83
83
Leak/Splash
61
61
Material Deformation
58
58
Appropriate Term/Code Not Available
42
42
Device Dislodged or Dislocated
39
39
Collapse
38
38
Off-Label Use
37
37
Material Separation
35
35
Break
33
33
Malposition of Device
26
26
Partial Blockage
23
23
Thickening of Material
23
23
Positioning Failure
22
22
Material Puncture/Hole
20
20
Material Too Rigid or Stiff
20
20
Migration
19
19
Therapeutic or Diagnostic Output Failure
18
18
Microbial Contamination of Device
15
15
Migration or Expulsion of Device
14
14
Material Twisted/Bent
13
13
Use of Device Problem
12
12
Material Integrity Problem
12
12
Material Perforation
12
12
Mechanical Jam
12
12
Improper or Incorrect Procedure or Method
12
12
Improper Flow or Infusion
11
11
Infusion or Flow Problem
11
11
Reflux within Device
11
11
Entrapment of Device
9
9
Difficult to Fold, Unfold or Collapse
9
9
Difficult or Delayed Separation
9
9
Unsealed Device Packaging
8
8
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
2515
2515
Aortic Valve Insufficiency/ Regurgitation
1448
1451
Aortic Valve Stenosis
985
988
Dyspnea
674
674
Heart Failure/Congestive Heart Failure
637
637
Endocarditis
536
536
No Clinical Signs, Symptoms or Conditions
446
449
No Information
308
308
Aortic Regurgitation
253
253
Mitral Valve Insufficiency/ Regurgitation
229
229
Hemorrhage/Bleeding
199
199
Stroke/CVA
197
197
Thrombosis/Thrombus
196
196
Aortic Insufficiency
185
185
Heart Block
178
178
Calcium Deposits/Calcification
164
164
Atrial Fibrillation
143
143
Fatigue
130
130
Mitral Valve Stenosis
104
104
Non specific EKG/ECG Changes
103
103
Renal Failure
93
93
Chest Pain
88
88
Valvular Insufficiency/ Regurgitation
88
88
Death
87
87
Cusp Tear
80
80
No Known Impact Or Consequence To Patient
79
79
Myocardial Infarction
76
76
Arrhythmia
71
71
Unspecified Infection
68
68
Obstruction/Occlusion
68
68
Pulmonary Valve Stenosis
68
68
Heart Failure
65
65
Complete Heart Block
56
56
Pseudoaneurysm
56
56
Cardiac Arrest
54
54
Cardiogenic Shock
48
48
Pulmonary Edema
46
46
Fever
46
46
Pulmonary Valve Insufficiency/ Regurgitation
46
46
Mitral Regurgitation
42
42
Rupture
42
42
Thrombocytopenia
42
42
Aneurysm
40
40
Bradycardia
40
40
Stenosis
39
39
Failure of Implant
38
38
Angina
38
38
Low Blood Pressure/ Hypotension
37
37
Sepsis
36
36
Pleural Effusion
34
34
Recalls
Manufacturer
Recall Class
Date Posted
1
Sorin Group Italia S.r.l.
II
Sep-18-2020
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