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)
2019 2020 2021 2022 2023 2024
4 6 9 8 9 3

MDR Year MDR Reports MDR Events
2019 350 350
2020 372 372
2021 287 287
2022 297 297
2023 455 455
2024 121 121

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 562 562
Insufficient Information 489 489
Incomplete Coaptation 143 143
Physical Resistance/Sticking 110 110
Perivalvular Leak 110 110
Fracture 100 100
Obstruction of Flow 78 78
Biocompatibility 78 78
Patient Device Interaction Problem 65 65
Detachment of Device or Device Component 64 64
Inadequacy of Device Shape and/or Size 59 59
Difficult to Open or Close 54 54
Material Separation 52 52
Gradient Increase 35 35
Patient-Device Incompatibility 32 32
Appropriate Term/Code Not Available 31 31
Backflow 28 28
Device Dislodged or Dislocated 22 22
Mechanical Jam 16 16
Device Stenosis 15 15
Break 12 12
No Apparent Adverse Event 12 12
Improper or Incorrect Procedure or Method 11 11
Central Regurgitation 10 10
Off-Label Use 10 10
Device Markings/Labelling Problem 8 8
Calcified 8 8
Material Split, Cut or Torn 8 8
Degraded 7 7
Use of Device Problem 6 6
Migration or Expulsion of Device 6 6
Material Integrity Problem 6 6
Crack 4 4
Device Damaged by Another Device 4 4
Leak/Splash 3 3
Mechanical Problem 3 3
Microbial Contamination of Device 3 3
Defective Device 2 2
Positioning Problem 2 2
Pacing Problem 2 2
Scratched Material 2 2
Material Too Rigid or Stiff 2 2
Product Quality Problem 2 2
Human-Device Interface Problem 2 2
Structural Problem 2 2
Material Frayed 2 2
Difficult or Delayed Positioning 2 2
Contamination /Decontamination Problem 2 2
Lack of Effect 1 1
Unraveled Material 1 1
Coagulation in Device or Device Ingredient 1 1
Material Puncture/Hole 1 1
Shipping Damage or Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Sense 1 1
Pitted 1 1
Burst Container or Vessel 1 1
Gas/Air Leak 1 1
Material Fragmentation 1 1
Device Handling Problem 1 1
Material Deformation 1 1
Partial Blockage 1 1
Insufficient Flow or Under Infusion 1 1
Mechanics Altered 1 1
Difficult to Insert 1 1
Malposition of Device 1 1
Material Perforation 1 1
Separation Problem 1 1
Noise, Audible 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 324 324
No Clinical Signs, Symptoms or Conditions 228 228
No Information 201 201
Endocarditis 121 121
Stroke/CVA 109 109
Hemorrhage/Bleeding 104 104
Thrombosis/Thrombus 98 98
No Known Impact Or Consequence To Patient 84 84
Death 80 80
Dyspnea 70 70
Atrial Fibrillation 69 69
Aortic Valve Insufficiency/ Regurgitation 68 68
Heart Failure/Congestive Heart Failure 60 60
Aortic Valve Stenosis 56 56
Thrombus 55 55
Heart Block 48 48
No Consequences Or Impact To Patient 41 41
Unspecified Infection 41 41
Valvular Insufficiency/ Regurgitation 38 38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
Mitral Valve Insufficiency/ Regurgitation 36 36
Corneal Pannus 34 34
Thromboembolism 31 31
Arrhythmia 30 30
Cardiac Arrest 29 29
Pericardial Effusion 29 29
No Code Available 28 28
Non specific EKG/ECG Changes 27 27
Myocardial Infarction 26 26
Renal Failure 26 26
Aortic Regurgitation 25 25
Obstruction/Occlusion 24 24
Thrombosis 23 23
Mitral Valve Stenosis 22 22
Pseudoaneurysm 22 22
Tachycardia 21 21
Mitral Regurgitation 21 21
Anemia 21 21
Pulmonary Edema 19 19
Pleural Effusion 18 18
Low Cardiac Output 18 18
Cardiac Tamponade 18 18
Hematoma 18 18
Hemolytic Anemia 17 17
Transient Ischemic Attack 16 16
Ventricular Fibrillation 15 15
Sepsis 15 15
Cardiogenic Shock 15 15
Heart Failure 15 15
Aortic Insufficiency 15 15
Embolism 14 14
Chest Pain 14 14
Hemolysis 14 14
Low Blood Pressure/ Hypotension 14 14
Insufficiency, Valvular 14 14
High Blood Pressure/ Hypertension 13 13
Pneumonia 12 12
Respiratory Insufficiency 12 12
Hypoxia 11 11
Aneurysm 10 10
Stenosis 10 10
Regurgitation 9 9
Complete Heart Block 9 9
Host-Tissue Reaction 9 9
Bradycardia 9 9
Failure of Implant 9 9
Mitral Insufficiency 9 9
Intracranial Hemorrhage 9 9
Foreign Body Reaction 9 9
Hemoptysis 8 8
Ischemia Stroke 8 8
Blood Loss 8 8
Fatigue 7 7
Angina 7 7
Atrial Flutter 7 7
Abscess 7 7
Occlusion 7 7
Paresis 7 7
Calcium Deposits/Calcification 6 6
Syncope/Fainting 6 6
Valvular Stenosis 6 6
Unspecified Heart Problem 5 5
Infarction, Cerebral 5 5
Septic Shock 5 5
Respiratory Failure 5 5
Regurgitation, Valvular 4 4
Cardiac Perforation 4 4
Pneumothorax 4 4
Congestive Heart Failure 4 4
Fever 4 4
Tricuspid Valve Insufficiency/ Regurgitation 4 4
Embolism/Embolus 4 4
Cardiovascular Insufficiency 4 4
Convulsion/Seizure 4 4
Multiple Organ Failure 3 3
Foreign Body In Patient 3 3
Foreign Body Embolism 3 3
Hemorrhagic Stroke 3 3
Pulmonary Hypertension 3 3
Unspecified Kidney or Urinary Problem 3 3

Recalls
Manufacturer Recall Class Date Posted
1 CryoLife, Inc. II Mar-28-2019
2 MEDTRONIC ATS MEDICAL, INC. II Mar-20-2020
-
-