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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 4

MDR Year MDR Reports MDR Events
2019 2278 2278
2020 2724 2724
2021 2346 5587
2022 2585 3754
2023 2476 2563
2024 735 735

Device Problems MDRs with this Device Problem Events in those MDRs
Incomplete Coaptation 3370 3401
Adverse Event Without Identified Device or Use Problem 3007 7469
Unintended Movement 2070 2070
Difficult to Open or Close 1743 1743
Difficult or Delayed Positioning 875 875
Difficult to Remove 763 763
Positioning Failure 690 690
Off-Label Use 542 542
Improper or Incorrect Procedure or Method 503 503
Migration 501 501
Entrapment of Device 493 493
Device Damaged by Another Device 464 464
Break 377 377
Physical Resistance/Sticking 352 352
Leak/Splash 299 299
Mechanical Jam 293 293
Expulsion 270 274
Difficult or Delayed Activation 264 264
Material Separation 181 181
Material Deformation 148 148
Retraction Problem 103 103
Activation Failure 101 101
Premature Activation 86 86
Material Split, Cut or Torn 84 84
Product Quality Problem 74 74
Unstable 63 63
Deformation Due to Compressive Stress 58 58
Noise, Audible 57 57
Difficult to Insert 50 50
Material Protrusion/Extrusion 35 35
Difficult to Advance 31 31
Crack 28 28
Stretched 27 27
Material Frayed 25 25
No Apparent Adverse Event 25 25
Patient Device Interaction Problem 22 22
Difficult to Flush 20 20
Device Difficult to Setup or Prepare 12 12
Activation, Positioning or Separation Problem 12 12
Air/Gas in Device 12 12
Tear, Rip or Hole in Device Packaging 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
Activation Problem 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
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 3920 4484
No Consequences Or Impact To Patient 1954 1954
Mitral Valve Insufficiency/ Regurgitation 1941 2844
Unspecified Tissue Injury 1490 1521
Mitral Regurgitation 1353 1353
Tissue Damage 896 896
Dyspnea 490 490
Foreign Body In Patient 448 452
Mitral Valve Stenosis 405 405
Heart Failure/Congestive Heart Failure 374 1082
Death 363 363
Heart Failure 325 325
No Patient Involvement 272 272
Stroke/CVA 265 280
Pericardial Effusion 252 252
Hemorrhage/Bleeding 229 411
Low Blood Pressure/ Hypotension 227 227
Insufficient Information 208 2047
Tricuspid Valve Insufficiency/ Regurgitation 153 153
Renal Failure 145 184
Embolism/Embolus 134 134
Air Embolism 111 111
Myocardial Infarction 110 140
Cardiac Arrest 109 167
Atrial Fibrillation 108 171
Endocarditis 107 116
Embolism 101 101
Thrombosis/Thrombus 101 101
Cardiogenic Shock 90 90
Cardiac Tamponade 89 89
Thrombosis 87 87
Tricuspid Regurgitation 85 85
Fatigue 73 73
Arrhythmia 69 69
Sepsis 69 69
Perforation 69 69
High Blood Pressure/ Hypertension 60 60
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 34 34
Non specific EKG/ECG Changes 32 32
Bradycardia 26 26
Hypoxia 26 26
Edema 23 23
Hematoma 21 37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Rupture 20 20
Ventricular Fibrillation 19 19
No Code Available 17 17
Cusp Tear 17 17
Failure of Implant 17 17
Ischemia 17 17
Pain 16 16
Hemolysis 16 16
Anemia 14 14
Intracranial Hemorrhage 14 16
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
Vascular Dissection 8 8
Multiple Organ Failure 8 8
Foreign Body Embolism 7 7
Syncope/Fainting 7 7
Inflammation 7 7
Hypersensitivity/Allergic reaction 6 6
Fistula 6 6
Diminished Pulse Pressure 6 6
Cardiac Perforation 6 6
Pseudoaneurysm 5 5
No Known Impact Or Consequence To Patient 5 5
Test Result 5 5
No Information 5 5
Renal Impairment 5 5
Atrial Flutter 5 5
Anaphylactic Shock 4 4
Seizures 4 4
Heart Block 4 4
Visual Disturbances 4 4
Dizziness 3 3
Unspecified Vascular Problem 3 3
Paresis 3 3
Aneurysm 3 3
Atrial Tachycardia 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 Edwards Lifesciences, LLC II Aug-29-2023
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