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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 1 8 5 6 4 3 9 1 5 12 20 3

MDR Year MDR Reports MDR Events
2014 484 484
2015 544 544
2016 826 826
2017 1138 1138
2018 1668 1668
2019 2278 2278
2020 2724 2724
2021 2346 5587
2022 2585 3754
2023 2476 2563
2024 552 552

Device Problems MDRs with this Device Problem Events in those MDRs
Incomplete Coaptation 4735 4766
Adverse Event Without Identified Device or Use Problem 3779 8241
Unintended Movement 2157 2157
Difficult to Open or Close 2047 2047
Difficult to Remove 1334 1334
Difficult or Delayed Positioning 1096 1096
Improper or Incorrect Procedure or Method 865 865
Positioning Failure 733 733
Device Damaged by Another Device 632 632
Entrapment of Device 616 616
Off-Label Use 611 611
Mechanical Jam 570 570
Break 563 563
Migration 547 547
Failure To Adhere Or Bond 516 516
Leak/Splash 437 437
Difficult To Position 420 420
Physical Resistance/Sticking 374 374
Expulsion 293 297
Difficult or Delayed Activation 291 291
Material Separation 196 196
Detachment Of Device Component 181 181
Material Deformation 163 163
Bent 147 147
Device Operates Differently Than Expected 127 127
Mechanical Problem 123 123
Physical Resistance 122 122
Retraction Problem 118 118
Premature Activation 98 98
Activation Failure 95 95
Material Split, Cut or Torn 92 92
Unstable 86 86
Product Quality Problem 81 81
Difficult to Insert 75 75
Deformation Due to Compressive Stress 70 70
Noise, Audible 60 60
Material Protrusion/Extrusion 53 53
Knotted 51 51
Stretched 48 48
Crack 36 36
Difficult to Advance 34 34
Torn Material 34 34
Difficult to Flush 31 31
Physical Property Issue 27 27
No Apparent Adverse Event 25 25
Material Frayed 25 25
Failure to Advance 19 19
Insufficient Information 19 19
Patient Device Interaction Problem 19 19
Tear, Rip or Hole in Device Packaging 15 15
Device Contamination with Chemical or Other Material 15 15
Loose or Intermittent Connection 15 15
Activation, Positioning or Separation Problem 14 14
Device Difficult to Setup or Prepare 13 13
Kinked 13 13
Air/Gas in Device 11 11
Detachment of Device or Device Component 10 10
Component Missing 9 9
Out-Of-Box Failure 8 8
Device Dislodged or Dislocated 6 6
Separation Failure 6 6
Device Markings/Labelling Problem 5 5
Defective Device 5 5
Malposition of Device 5 5
Device Expiration Issue 5 5
Material Twisted/Bent 4 4
Therapeutic or Diagnostic Output Failure 3 3
Appropriate Term/Code Not Available 3 3
Component Misassembled 3 3
Activation Problem 3 3
Failure to Align 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Device-Device Incompatibility 3 3
Peeled/Delaminated 2 2
Flushing Problem 2 2
Device Slipped 2 2
Migration or Expulsion of Device 2 2
Misconnection 2 2
Unsealed Device Packaging 2 2
Separation Problem 2 2
Inaccurate Information 2 2
Positioning Problem 2 2
Scratched Material 1 1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 1 1
Misassembly by Users 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Firing Problem 1 1
Difficult or Delayed Separation 1 1
Particulates 1 1
Fluid/Blood Leak 1 1
Biofilm coating in Device 1 1
Loss of or Failure to Bond 1 1
Problem with Removal of Enzymatic Cleaner 1 1
System fails to activate 1 1
Device Inoperable 1 1
Use of Device Problem 1 1
Failure to Disconnect 1 1
Patient-Device Incompatibility 1 1
Aspiration Issue 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3991 3991
No Clinical Signs, Symptoms or Conditions 3829 4393
Mitral Regurgitation 2609 2609
Mitral Valve Insufficiency/ Regurgitation 1897 2800
Tissue Damage 1657 1657
Unspecified Tissue Injury 1459 1490
Dyspnea 728 728
Foreign Body In Patient 614 618
Death 596 596
No Patient Involvement 526 526
Mitral Valve Stenosis 510 510
Heart Failure 480 481
Heart Failure/Congestive Heart Failure 366 1074
Low Blood Pressure/ Hypotension 337 337
Stroke/CVA 313 328
Pericardial Effusion 289 289
Hemorrhage/Bleeding 262 444
Insufficient Information 208 2047
Renal Failure 178 217
Embolism 169 169
Cardiac Arrest 162 220
Thrombosis 154 154
Air Embolism 148 148
Tricuspid Valve Insufficiency/ Regurgitation 145 145
Atrial Fibrillation 143 206
Embolism/Embolus 130 130
Endocarditis 129 138
Myocardial Infarction 127 157
Cardiogenic Shock 126 126
Tricuspid Regurgitation 121 121
Cardiac Tamponade 110 110
Fatigue 99 99
Thrombosis/Thrombus 98 98
Atrial Perforation 90 90
Arrhythmia 90 91
High Blood Pressure/ Hypertension 80 80
Sepsis 79 79
Respiratory Failure 79 80
Perforation 77 77
Pulmonary Edema 71 71
Unspecified Infection 64 80
Tachycardia 60 60
Fever 59 59
No Code Available 51 51
Angina 48 48
Edema 47 47
Non specific EKG/ECG Changes 39 39
Shock 39 39
Transient Ischemic Attack 39 46
Swelling/ Edema 33 33
Ventricular Fibrillation 31 31
Bradycardia 29 29
Hematoma 26 42
Hypoxia 26 26
Anemia 24 24
Hemolysis 21 21
Ventricular Tachycardia 20 20
Respiratory Distress 20 20
Rupture 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Neurological Deficit/Dysfunction 19 19
Pain 18 18
Failure of Implant 17 17
Ischemia 17 17
Weakness 16 16
Cusp Tear 16 16
Intracranial Hemorrhage 15 17
Cardiac Enzyme Elevation 14 14
No Known Impact Or Consequence To Patient 14 14
Perforation of Vessels 12 22
Pleural Effusion 12 12
Nausea 12 12
No Information 12 12
Test Result 11 11
Pulmonary Embolism 10 10
Multiple Organ Failure 9 9
Tricuspid Valve Stenosis 9 9
Nervous System Injury 8 11
Vascular Dissection 8 8
Inflammation 8 8
Atrial Flutter 7 7
Fistula 7 7
Syncope/Fainting 7 7
Dizziness 7 7
Visual Disturbances 6 6
Foreign Body Embolism 6 6
Pseudoaneurysm 6 6
Diminished Pulse Pressure 6 6
Atrial Tachycardia 6 6
Occlusion 6 6
Hypersensitivity/Allergic reaction 6 6
Cardiac Perforation 5 5
Renal Impairment 5 5
Seizures 4 4
Anaphylactic Shock 4 4
Aneurysm 3 3
Syncope 3 3
Intimal Dissection 3 3
Calcium Deposits/Calcification 3 3
Coagulation Disorder 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Oct-20-2022
2 Abbott Vascular II May-29-2019
3 Abbott Vascular I Mar-07-2016
4 Edwards Lifesciences, LLC II Aug-29-2023
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