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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 0

MDR Year MDR Reports MDR Events
2020 372 372
2021 287 287
2022 297 297
2023 455 455
2024 406 406
2025 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 567 567
Insufficient Information 410 410
Physical Resistance/Sticking 151 151
Incomplete Coaptation 150 150
Perivalvular Leak 114 114
Patient Device Interaction Problem 113 113
Fracture 86 86
Detachment of Device or Device Component 72 72
Biocompatibility 70 70
Inadequacy of Device Shape and/or Size 52 52
Material Separation 48 48
Obstruction of Flow 47 47
Difficult to Open or Close 44 44
Patient-Device Incompatibility 36 36
Gradient Increase 31 31
Device Stenosis 29 29
Backflow 26 26
Central Regurgitation 25 25
Improper or Incorrect Procedure or Method 14 14
Appropriate Term/Code Not Available 13 13
Device Dislodged or Dislocated 12 12
Mechanical Jam 11 11
Break 11 11
Off-Label Use 11 11
Degraded 7 7
Material Integrity Problem 7 7
Device Markings/Labelling Problem 6 6
No Apparent Adverse Event 6 6
Material Split, Cut or Torn 5 5
Use of Device Problem 5 5
Device Damaged by Another Device 4 4
Contamination /Decontamination Problem 4 4
Migration or Expulsion of Device 4 4
Packaging Problem 3 3
Leak/Splash 3 3
Crack 3 3
Unsealed Device Packaging 3 3
Product Quality Problem 3 3
Material Frayed 2 2
Calcified 2 2
Mechanical Problem 2 2
Human-Device Interface Problem 2 2
Malposition of Device 1 1
Partial Blockage 1 1
Microbial Contamination of Device 1 1
Expiration Date Error 1 1
Thickening of Material 1 1
Material Deformation 1 1
Material Puncture/Hole 1 1
Burst Container or Vessel 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 414 414
No Clinical Signs, Symptoms or Conditions 310 310
Hemorrhage/Bleeding 131 131
Endocarditis 122 122
Stroke/CVA 122 122
Thrombosis/Thrombus 122 122
No Information 98 98
Aortic Valve Insufficiency/ Regurgitation 81 81
Heart Failure/Congestive Heart Failure 78 78
Dyspnea 77 77
Atrial Fibrillation 76 76
Heart Block 57 57
Aortic Valve Stenosis 55 55
Death 54 54
Valvular Insufficiency/ Regurgitation 51 51
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Mitral Valve Insufficiency/ Regurgitation 42 42
Non specific EKG/ECG Changes 41 41
Thromboembolism 37 37
Arrhythmia 35 35
Renal Failure 34 34
Unspecified Infection 32 32
Pericardial Effusion 30 30
Obstruction/Occlusion 29 29
Pseudoaneurysm 29 29
Anemia 28 28
No Known Impact Or Consequence To Patient 28 28
Myocardial Infarction 27 27
Cardiac Arrest 27 27
No Consequences Or Impact To Patient 27 27
Thrombus 26 26
Tachycardia 25 25
Pleural Effusion 22 22
Mitral Valve Stenosis 21 21
Hematoma 19 19
Transient Ischemic Attack 19 19
Cardiac Tamponade 18 18
Hemolytic Anemia 17 17
Chest Pain 17 17
Hemolysis 16 16
Sepsis 16 16
Low Blood Pressure/ Hypotension 15 15
Cardiogenic Shock 15 15
Thrombosis 15 15
Low Cardiac Output 14 14
High Blood Pressure/ Hypertension 14 14
Ventricular Fibrillation 14 14
Respiratory Insufficiency 14 14
Pulmonary Edema 13 13
Mitral Regurgitation 12 12

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