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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)
2019 2020 2021 2022 2023 2024
9 1 5 12 20 3

MDR Year MDR Reports MDR Events
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 3333 3364
Adverse Event Without Identified Device or Use Problem 2978 7440
Unintended Movement 2033 2033
Difficult to Open or Close 1722 1722
Difficult or Delayed Positioning 865 865
Difficult to Remove 748 748
Positioning Failure 682 682
Off-Label Use 538 538
Improper or Incorrect Procedure or Method 498 498
Migration 489 489
Entrapment of Device 486 486
Device Damaged by Another Device 463 463
Break 371 371
Physical Resistance/Sticking 348 348
Leak/Splash 297 297
Mechanical Jam 291 291
Expulsion 266 270
Difficult or Delayed Activation 259 259
Material Separation 180 180
Material Deformation 147 147
Retraction Problem 103 103
Activation Failure 94 94
Material Split, Cut or Torn 84 84
Premature Activation 83 83
Product Quality Problem 73 73
Unstable 63 63
Noise, Audible 56 56
Deformation Due to Compressive Stress 56 56
Difficult to Insert 48 48
Material Protrusion/Extrusion 35 35
Difficult to Advance 30 30
Stretched 27 27
Crack 26 26
Material Frayed 25 25
No Apparent Adverse Event 24 24
Difficult to Flush 20 20
Patient Device Interaction Problem 19 19
Activation, Positioning or Separation Problem 12 12
Device Difficult to Setup or Prepare 12 12
Tear, Rip or Hole in Device Packaging 11 11
Air/Gas in Device 11 11
Failure to Advance 10 10
Detachment of Device or Device Component 10 10
Insufficient Information 9 9
Loose or Intermittent Connection 9 9
Mechanical Problem 8 8
Device Contamination with Chemical or Other Material 8 8
Device Dislodged or Dislocated 5 5
Malposition of Device 5 5
Separation Failure 5 5
Component Missing 5 5
Defective Device 4 4
Device-Device Incompatibility 3 3
Device Markings/Labelling Problem 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Component Misassembled 3 3
Activation Problem 3 3
Separation Problem 2 2
Appropriate Term/Code Not Available 2 2
Failure to Align 2 2
Migration or Expulsion of Device 2 2
Therapeutic or Diagnostic Output Failure 2 2
Inaccurate Information 2 2
Firing Problem 1 1
Misconnection 1 1
Particulates 1 1
Peeled/Delaminated 1 1
Biofilm coating in Device 1 1
Use of Device Problem 1 1
System fails to activate 1 1
Difficult or Delayed Separation 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Misassembly by Users 1 1
Positioning Problem 1 1
Scratched Material 1 1
Patient-Device Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3829 4393
No Consequences Or Impact To Patient 1954 1954
Mitral Valve Insufficiency/ Regurgitation 1897 2800
Unspecified Tissue Injury 1459 1490
Mitral Regurgitation 1353 1353
Tissue Damage 896 896
Dyspnea 480 480
Foreign Body In Patient 445 449
Mitral Valve Stenosis 401 401
Heart Failure/Congestive Heart Failure 366 1074
Death 363 363
Heart Failure 325 325
No Patient Involvement 272 272
Stroke/CVA 262 277
Pericardial Effusion 247 247
Hemorrhage/Bleeding 227 409
Low Blood Pressure/ Hypotension 224 224
Insufficient Information 208 2047
Tricuspid Valve Insufficiency/ Regurgitation 145 145
Renal Failure 145 184
Embolism/Embolus 130 130
Air Embolism 109 109
Cardiac Arrest 109 167
Atrial Fibrillation 108 171
Myocardial Infarction 108 138
Endocarditis 107 116
Embolism 101 101
Thrombosis/Thrombus 98 98
Cardiogenic Shock 90 90
Cardiac Tamponade 89 89
Thrombosis 87 87
Tricuspid Regurgitation 85 85
Fatigue 71 71
Sepsis 69 69
Arrhythmia 68 68
Perforation 66 66
High Blood Pressure/ Hypertension 59 59
Tachycardia 58 58
Pulmonary Edema 55 55
Respiratory Failure 53 53
Fever 44 44
Unspecified Infection 42 58
Atrial Perforation 42 42
Angina 37 37
Transient Ischemic Attack 35 42
Shock 35 35
Swelling/ Edema 33 33
Non specific EKG/ECG Changes 31 31
Hypoxia 26 26
Bradycardia 25 25
Edema 23 23
Hematoma 20 36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Rupture 20 20
Ventricular Fibrillation 19 19
No Code Available 17 17
Failure of Implant 17 17
Ischemia 17 17
Pain 16 16
Hemolysis 16 16
Cusp Tear 16 16
Anemia 14 14
Intracranial Hemorrhage 13 15
Pleural Effusion 12 12
Perforation of Vessels 12 22
Respiratory Distress 11 11
Nausea 10 10
Cardiac Enzyme Elevation 10 10
Weakness 10 10
Ventricular Tachycardia 9 9
Tricuspid Valve Stenosis 9 9
Neurological Deficit/Dysfunction 9 9
Pulmonary Embolism 8 8
Nervous System Injury 8 11
Multiple Organ Failure 8 8
Vascular Dissection 8 8
Syncope/Fainting 7 7
Inflammation 7 7
Hypersensitivity/Allergic reaction 6 6
Foreign Body Embolism 6 6
Diminished Pulse Pressure 6 6
No Known Impact Or Consequence To Patient 5 5
Test Result 5 5
Cardiac Perforation 5 5
Pseudoaneurysm 5 5
No Information 5 5
Renal Impairment 5 5
Atrial Flutter 5 5
Fistula 5 5
Anaphylactic Shock 4 4
Seizures 4 4
Visual Disturbances 4 4
Dizziness 3 3
Unspecified Vascular Problem 3 3
Heart Block 3 3
Paresis 3 3
Atrial Tachycardia 3 3
Calcium Deposits/Calcification 3 3
Coagulation Disorder 3 3
Encephalopathy 2 2

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