Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back to Search Results
Device heart-valve, mechanical
Product CodeLWQ
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
6 9 8 9 6 2

MDR Year MDR Reports MDR Events
2020 372 372
2021 287 287
2022 297 297
2023 455 455
2024 406 406
2025 131 131

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 588 588
Insufficient Information 431 431
Physical Resistance/Sticking 169 169
Incomplete Coaptation 161 161
Patient Device Interaction Problem 124 124
Perivalvular Leak 120 120
Fracture 88 88
Detachment of Device or Device Component 79 79
Biocompatibility 70 70
Inadequacy of Device Shape and/or Size 56 56
Material Separation 48 48
Obstruction of Flow 47 47
Difficult to Open or Close 44 44
Patient-Device Incompatibility 38 38
Gradient Increase 32 32
Device Stenosis 32 32
Central Regurgitation 29 29
Backflow 26 26
Improper or Incorrect Procedure or Method 15 15
Appropriate Term/Code Not Available 13 13
Device Dislodged or Dislocated 12 12
Break 11 11
Off-Label Use 11 11
Mechanical Jam 11 11
Device Markings/Labelling Problem 7 7
Material Integrity Problem 7 7
Degraded 7 7
No Apparent Adverse Event 6 6
Material Split, Cut or Torn 5 5
Use of Device Problem 5 5
Leak/Splash 4 4
Migration or Expulsion of Device 4 4
Contamination /Decontamination Problem 4 4
Device Damaged by Another Device 4 4
Crack 3 3
Unsealed Device Packaging 3 3
Packaging Problem 3 3
Product Quality Problem 3 3
Calcified 2 2
Human-Device Interface Problem 2 2
Mechanical Problem 2 2
Material Frayed 2 2
Device Handling Problem 1 1
Material Deformation 1 1
Lack of Effect 1 1
Mechanics Altered 1 1
Insufficient Flow or Under Infusion 1 1
Partial Blockage 1 1
Shipping Damage or Problem 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 451 451
No Clinical Signs, Symptoms or Conditions 332 332
Hemorrhage/Bleeding 135 135
Stroke/CVA 132 132
Endocarditis 127 127
Thrombosis/Thrombus 126 126
No Information 98 98
Aortic Valve Insufficiency/ Regurgitation 86 86
Dyspnea 83 83
Heart Failure/Congestive Heart Failure 82 82
Atrial Fibrillation 78 78
Heart Block 60 60
Aortic Valve Stenosis 56 56
Death 54 54
Valvular Insufficiency/ Regurgitation 52 52
Mitral Valve Insufficiency/ Regurgitation 47 47
Non specific EKG/ECG Changes 46 46
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Thromboembolism 40 40
Arrhythmia 36 36
Renal Failure 35 35
Unspecified Infection 34 34
Pericardial Effusion 32 32
Pseudoaneurysm 30 30
Obstruction/Occlusion 29 29
Anemia 29 29
No Known Impact Or Consequence To Patient 28 28
Myocardial Infarction 28 28
Cardiac Arrest 27 27
No Consequences Or Impact To Patient 27 27
Thrombus 26 26
Tachycardia 25 25
Pleural Effusion 24 24
Mitral Valve Stenosis 23 23
Hematoma 20 20
Transient Ischemic Attack 19 19
Cardiac Tamponade 18 18
Hemolysis 17 17
Hemolytic Anemia 17 17
Chest Pain 17 17
Low Blood Pressure/ Hypotension 16 16
Sepsis 16 16
Thrombosis 15 15
Cardiogenic Shock 15 15
Respiratory Insufficiency 14 14
High Blood Pressure/ Hypertension 14 14
Ventricular Fibrillation 14 14
Pneumonia 14 14
Pulmonary Edema 14 14
Low Cardiac Output 14 14

Recalls
Manufacturer Recall Class Date Posted
1 MEDTRONIC ATS MEDICAL, INC. II Mar-20-2020
-
-