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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 7

MDR Year MDR Reports MDR Events
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 3489 3520
Adverse Event Without Identified Device or Use Problem 3086 7548
Unintended Movement 2163 2163
Difficult to Open or Close 1812 1812
Difficult or Delayed Positioning 916 916
Difficult to Remove 796 796
Positioning Failure 714 714
Off-Label Use 561 561
Migration 523 523
Improper or Incorrect Procedure or Method 519 519
Entrapment of Device 515 515
Device Damaged by Another Device 484 484
Break 390 390
Physical Resistance/Sticking 356 356
Leak/Splash 304 304
Mechanical Jam 303 303
Expulsion 276 280
Difficult or Delayed Activation 273 273
Material Separation 184 184
Material Deformation 152 152
Activation Failure 123 123
Retraction Problem 104 104
Premature Activation 88 88
Material Split, Cut or Torn 86 86
Product Quality Problem 80 80
Unstable 63 63
Deformation Due to Compressive Stress 62 62
Noise, Audible 59 59
Difficult to Insert 55 55
Material Protrusion/Extrusion 35 35
Difficult to Advance 31 31
Patient Device Interaction Problem 30 30
Crack 30 30
Stretched 28 28
Material Frayed 25 25
No Apparent Adverse Event 25 25
Difficult to Flush 20 20
Failure to Advance 15 15
Air/Gas in Device 14 14
Device Difficult to Setup or Prepare 12 12
Activation, Positioning or Separation Problem 12 12
Tear, Rip or Hole in Device Packaging 11 11
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
Malposition of Device 6 6
Separation Failure 6 6
Component Missing 5 5
Device Dislodged or Dislocated 5 5
Activation Problem 4 4
Defective Device 4 4
Component Misassembled 3 3
Device-Device Incompatibility 3 3
Device Markings/Labelling Problem 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Appropriate Term/Code Not Available 2 2
Separation Problem 2 2
Failure to Align 2 2
Use of Device Problem 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
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 4165 4729
Mitral Valve Insufficiency/ Regurgitation 2085 2988
No Consequences Or Impact To Patient 1954 1954
Unspecified Tissue Injury 1591 1622
Mitral Regurgitation 1353 1353
Tissue Damage 896 896
Dyspnea 513 513
Foreign Body In Patient 459 463
Mitral Valve Stenosis 417 417
Heart Failure/Congestive Heart Failure 403 1111
Death 363 363
Heart Failure 325 325
No Patient Involvement 272 272
Stroke/CVA 271 286
Pericardial Effusion 260 260
Hemorrhage/Bleeding 237 419
Low Blood Pressure/ Hypotension 236 236
Insufficient Information 208 2047
Tricuspid Valve Insufficiency/ Regurgitation 175 175
Renal Failure 151 190
Embolism/Embolus 139 139
Air Embolism 114 114
Atrial Fibrillation 113 176
Cardiac Arrest 111 169
Myocardial Infarction 111 141
Thrombosis/Thrombus 109 109
Endocarditis 108 117
Embolism 101 101
Cardiac Tamponade 95 95
Cardiogenic Shock 91 91
Thrombosis 87 87
Tricuspid Regurgitation 85 85
Fatigue 78 78
Arrhythmia 73 73
Perforation 71 71
Sepsis 69 69
Tachycardia 62 62
High Blood Pressure/ Hypertension 61 61
Pulmonary Edema 57 57
Respiratory Failure 53 53
Unspecified Infection 46 62
Fever 44 44
Atrial Perforation 42 42
Angina 37 37
Transient Ischemic Attack 36 43
Shock 35 35
Swelling/ Edema 35 35
Non specific EKG/ECG Changes 33 33
Hypoxia 28 28
Bradycardia 26 26
Edema 23 23
Hematoma 22 38
Rupture 22 22
Cusp Tear 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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
Anemia 14 14
Intracranial Hemorrhage 14 16
Perforation of Vessels 14 24
Pleural Effusion 12 12
Respiratory Distress 11 11
Vascular Dissection 11 11
Weakness 10 10
Nausea 10 10
Cardiac Enzyme Elevation 10 10
Pulmonary Embolism 9 9
Neurological Deficit/Dysfunction 9 9
Ventricular Tachycardia 9 9
Tricuspid Valve Stenosis 9 9
Cardiac Perforation 8 8
Nervous System Injury 8 11
Multiple Organ Failure 8 8
Foreign Body Embolism 8 8
Syncope/Fainting 7 7
Pseudoaneurysm 7 7
Inflammation 7 7
Hypersensitivity/Allergic reaction 6 6
Atrial Flutter 6 6
Fistula 6 6
Diminished Pulse Pressure 6 6
No Known Impact Or Consequence To Patient 5 5
Test Result 5 5
Visual Disturbances 5 5
Heart Block 5 5
No Information 5 5
Renal Impairment 5 5
Anaphylactic Shock 4 4
Seizures 4 4
Paresis 3 3
Aneurysm 3 3
Atrial Tachycardia 3 3
Calcium Deposits/Calcification 3 3
Coagulation Disorder 3 3
Unspecified Vascular Problem 3 3
Dizziness 3 3

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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