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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mitral valve repair devices
Definition To repair the mitral valve by coapting the valve leaflets to prevent mitral regurgitation. These devices are different from the classified device (annuloplasty rings) in that a cardiotomy is not required to place them, some of them are placed percutaneously, and they definitely are not rings that are sewn on to the valve annulus.
Product CodeNKM
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
3 9 1 5 12 1

MDR Year MDR Reports MDR Events
2018 1668 1668
2019 2278 2278
2020 2724 2724
2021 2346 5587
2022 2586 3755

Device Problems MDRs with this Device Problem Events in those MDRs
Incomplete Coaptation 3103 3134
Adverse Event Without Identified Device or Use Problem 2732 7107
Unintended Movement 1676 1676
Difficult to Open or Close 1408 1408
Difficult to Remove 747 747
Difficult or Delayed Positioning 722 722
Positioning Failure 544 544
Improper or Incorrect Procedure or Method 529 529
Off-Label Use 509 509
Device Damaged by Another Device 425 425
Migration 421 421
Entrapment of Device 379 379
Break 357 357
Physical Resistance/Sticking 311 311
Mechanical Jam 298 298
Leak/Splash 297 297
Expulsion 229 233
Difficult or Delayed Activation 228 228
Material Separation 185 185
Material Deformation 109 109
Retraction Problem 93 93
Failure To Adhere Or Bond 93 93
Material Split, Cut or Torn 77 77
Unstable 69 69
Product Quality Problem 66 66
Premature Activation 65 65
Difficult To Position 55 55
Deformation Due to Compressive Stress 55 55
Noise, Audible 49 49
Mechanical Problem 42 42
Material Protrusion/Extrusion 39 39
Difficult to Insert 35 35
Stretched 31 31
Difficult to Advance 28 28
Detachment Of Device Component 27 27
Activation Failure 26 26
Difficult to Flush 25 25
Crack 24 24
Material Frayed 18 18
Bent 18 18
Physical Resistance 17 17
No Apparent Adverse Event 16 16
Device Operates Differently Than Expected 14 14
Torn Material 13 13
Device Contamination with Chemical or Other Material 12 12
Activation, Positioning or Separation Problem 12 12
Insufficient Information 11 11
Tear, Rip or Hole in Device Packaging 10 10
Failure to Advance 9 9
Loose or Intermittent Connection 9 9
Knotted 8 8
Physical Property Issue 5 5
Device Dislodged or Dislocated 4 4
Component Missing 4 4
Detachment of Device or Device Component 4 4
Device Markings/Labelling Problem 4 4
Device Misassembled During Manufacturing /Shipping 3 3
Defective Device 3 3
Kinked 3 3
Component Misassembled 3 3
Appropriate Term/Code Not Available 2 2
Inaccurate Information 2 2
Device Difficult to Setup or Prepare 2 2
Migration or Expulsion of Device 2 2
Misconnection 2 2
Material Twisted/Bent 2 2
Therapeutic or Diagnostic Output Failure 2 2
Positioning Problem 1 1
Scratched Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Form Staple 1 1
Out-Of-Box Failure 1 1
Separation Failure 1 1
Failure to Align 1 1
Particulates 1 1
System fails to activate 1 1
Device Inoperable 1 1
Flushing Problem 1 1
Biofilm coating in Device 1 1
Loss of or Failure to Bond 1 1
Device Expiration Issue 1 1
Firing Problem 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2679 2679
No Clinical Signs, Symptoms or Conditions 2342 2872
Mitral Regurgitation 1779 1779
Tissue Damage 1198 1198
Mitral Valve Insufficiency/ Regurgitation 1098 1975
Unspecified Tissue Injury 869 900
Dyspnea 447 447
Foreign Body In Patient 426 430
Death 414 414
Mitral Valve Stenosis 399 399
Heart Failure 387 387
No Patient Involvement 366 366
Heart Failure/Congestive Heart Failure 234 922
Stroke/CVA 224 239
Pericardial Effusion 221 221
Low Blood Pressure/ Hypotension 199 199
Hemorrhage/Bleeding 195 377
Insufficient Information 182 2014
Renal Failure 137 176
Embolism 129 129
Tricuspid Regurgitation 110 110
Thrombosis 109 109
Atrial Fibrillation 103 166
Cardiac Arrest 99 157
Air Embolism 93 93
Endocarditis 93 102
Cardiogenic Shock 90 90
Myocardial Infarction 85 115
Cardiac Tamponade 72 72
Tricuspid Valve Insufficiency/ Regurgitation 68 68
Embolism/Embolus 68 68
Fatigue 67 67
Sepsis 64 64
Thrombosis/Thrombus 58 58
Atrial Perforation 53 53
Respiratory Failure 52 52
Arrhythmia 52 52
Perforation 50 50
High Blood Pressure/ Hypertension 47 47
Pulmonary Edema 46 46
Tachycardia 41 41
Fever 40 40
Unspecified Infection 39 55
Edema 31 31
Transient Ischemic Attack 31 38
Angina 29 29
Shock 29 29
Non specific EKG/ECG Changes 23 23
Bradycardia 20 20
Anemia 19 19
Hemolysis 19 19
No Code Available 19 19
Ventricular Fibrillation 18 18
Respiratory Distress 17 17
Hematoma 17 33
Ischemia 16 16
Swelling/ Edema 16 16
Failure of Implant 14 14
Hypoxia 13 13
Neurological Deficit/Dysfunction 12 12
Weakness 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Cardiac Enzyme Elevation 11 11
Intracranial Hemorrhage 10 12
Ventricular Tachycardia 10 10
No Known Impact Or Consequence To Patient 10 10
Test Result 9 9
Tricuspid Valve Stenosis 9 9
Nausea 9 9
Pain 9 9
Inflammation 7 7
Fistula 7 7
Nervous System Injury 7 10
Perforation of Vessels 6 16
No Information 6 6
Pulmonary Embolism 6 6
Pleural Effusion 6 6
Hypersensitivity/Allergic reaction 5 5
Atrial Flutter 5 5
Multiple Organ Failure 5 5
Visual Disturbances 5 5
Pseudoaneurysm 5 5
Diminished Pulse Pressure 4 4
Dizziness 4 4
Rupture 4 4
Renal Impairment 4 4
Seizures 4 4
Atrial Tachycardia 3 3
Anaphylactic Shock 3 3
Cusp Tear 3 3
Vascular Dissection 3 3
Tissue Breakdown 2 2
Unspecified Kidney or Urinary Problem 2 2
Prolapse 2 2
Convulsion/Seizure 2 2
Syncope/Fainting 2 2
Aneurysm 2 2
Syncope 2 2
Intimal Dissection 2 2
Calcium Deposits/Calcification 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Oct-20-2022
2 Abbott Vascular II May-29-2019
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