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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 7

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 1241 1241

Device Problems MDRs with this Device Problem Events in those MDRs
Incomplete Coaptation 4891 4922
Adverse Event Without Identified Device or Use Problem 3887 8349
Unintended Movement 2287 2287
Difficult to Open or Close 2137 2137
Difficult to Remove 1382 1382
Difficult or Delayed Positioning 1147 1147
Improper or Incorrect Procedure or Method 886 886
Positioning Failure 765 765
Device Damaged by Another Device 653 653
Entrapment of Device 645 645
Off-Label Use 634 634
Break 582 582
Mechanical Jam 582 582
Migration 581 581
Failure To Adhere Or Bond 516 516
Leak/Splash 444 444
Difficult To Position 420 420
Physical Resistance/Sticking 382 382
Difficult or Delayed Activation 305 305
Expulsion 303 307
Material Separation 200 200
Detachment Of Device Component 181 181
Material Deformation 168 168
Bent 147 147
Device Operates Differently Than Expected 127 127
Activation Failure 124 124
Mechanical Problem 123 123
Physical Resistance 122 122
Retraction Problem 119 119
Premature Activation 103 103
Material Split, Cut or Torn 94 94
Product Quality Problem 88 88
Unstable 86 86
Difficult to Insert 82 82
Deformation Due to Compressive Stress 76 76
Noise, Audible 63 63
Material Protrusion/Extrusion 53 53
Knotted 51 51
Stretched 49 49
Crack 40 40
Difficult to Advance 35 35
Torn Material 34 34
Difficult to Flush 31 31
Patient Device Interaction Problem 30 30
Physical Property Issue 27 27
No Apparent Adverse Event 26 26
Material Frayed 25 25
Failure to Advance 24 24
Insufficient Information 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
Air/Gas in Device 14 14
Device Difficult to Setup or Prepare 13 13
Kinked 13 13
Detachment of Device or Device Component 10 10
Component Missing 9 9
Out-Of-Box Failure 8 8
Separation Failure 7 7
Malposition of Device 6 6
Device Dislodged or Dislocated 6 6
Device Markings/Labelling Problem 5 5
Defective Device 5 5
Device Expiration Issue 5 5
Activation Problem 4 4
Material Twisted/Bent 4 4
Therapeutic or Diagnostic Output Failure 3 3
Appropriate Term/Code Not Available 3 3
Component Misassembled 3 3
Failure to Align 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Device-Device Incompatibility 3 3
Peeled/Delaminated 2 2
Use of Device Problem 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
Difficult or Delayed Separation 1 1
Firing Problem 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
Failure to Disconnect 1 1
Failure to Form Staple 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4165 4729
No Consequences Or Impact To Patient 3991 3991
Mitral Regurgitation 2609 2609
Mitral Valve Insufficiency/ Regurgitation 2085 2988
Tissue Damage 1657 1657
Unspecified Tissue Injury 1591 1622
Dyspnea 761 761
Foreign Body In Patient 628 632
Death 596 596
Mitral Valve Stenosis 526 526
No Patient Involvement 526 526
Heart Failure 480 481
Heart Failure/Congestive Heart Failure 403 1111
Low Blood Pressure/ Hypotension 349 349
Stroke/CVA 322 337
Pericardial Effusion 302 302
Hemorrhage/Bleeding 272 454
Insufficient Information 208 2047
Renal Failure 184 223
Tricuspid Valve Insufficiency/ Regurgitation 175 175
Embolism 169 169
Cardiac Arrest 164 222
Thrombosis 154 154
Air Embolism 153 153
Atrial Fibrillation 148 211
Embolism/Embolus 139 139
Endocarditis 130 139
Myocardial Infarction 130 160
Cardiogenic Shock 127 127
Tricuspid Regurgitation 121 121
Cardiac Tamponade 116 116
Thrombosis/Thrombus 109 109
Fatigue 106 106
Arrhythmia 95 96
Atrial Perforation 90 90
Perforation 82 82
High Blood Pressure/ Hypertension 82 82
Respiratory Failure 79 80
Sepsis 79 79
Pulmonary Edema 73 73
Unspecified Infection 68 84
Tachycardia 64 64
Fever 59 59
No Code Available 51 51
Angina 48 48
Edema 47 47
Non specific EKG/ECG Changes 41 41
Transient Ischemic Attack 40 47
Shock 39 39
Swelling/ Edema 35 35
Ventricular Fibrillation 31 31
Bradycardia 30 30
Hematoma 28 44
Hypoxia 28 28
Anemia 24 24
Rupture 22 22
Cusp Tear 21 21
Hemolysis 21 21
Ventricular Tachycardia 20 20
Respiratory Distress 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Neurological Deficit/Dysfunction 19 19
Pain 18 18
Ischemia 17 17
Failure of Implant 17 17
Intracranial Hemorrhage 16 18
Weakness 16 16
Perforation of Vessels 14 24
No Known Impact Or Consequence To Patient 14 14
Cardiac Enzyme Elevation 14 14
Nausea 12 12
Pleural Effusion 12 12
No Information 12 12
Test Result 11 11
Vascular Dissection 11 11
Pulmonary Embolism 11 11
Multiple Organ Failure 9 9
Tricuspid Valve Stenosis 9 9
Nervous System Injury 8 11
Foreign Body Embolism 8 8
Pseudoaneurysm 8 8
Cardiac Perforation 8 8
Atrial Flutter 8 8
Fistula 8 8
Inflammation 8 8
Syncope/Fainting 7 7
Visual Disturbances 7 7
Dizziness 7 7
Diminished Pulse Pressure 6 6
Hypersensitivity/Allergic reaction 6 6
Occlusion 6 6
Atrial Tachycardia 6 6
Heart Block 5 5
Renal Impairment 5 5
Seizures 4 4
Aneurysm 4 4
Anaphylactic Shock 4 4
Syncope 3 3
Intimal Dissection 3 3
Calcium Deposits/Calcification 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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