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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 2

MDR Year MDR Reports MDR Events
2019 2278 2278
2020 2724 2724
2021 2346 5587
2022 2585 3754
2023 2476 2563
2024 178 178

Device Problems MDRs with this Device Problem Events in those MDRs
Incomplete Coaptation 3244 3275
Adverse Event Without Identified Device or Use Problem 2917 7379
Unintended Movement 1979 1979
Difficult to Open or Close 1660 1660
Difficult or Delayed Positioning 830 830
Difficult to Remove 730 730
Positioning Failure 663 663
Off-Label Use 526 526
Improper or Incorrect Procedure or Method 484 484
Migration 473 473
Entrapment of Device 462 462
Device Damaged by Another Device 448 448
Break 363 363
Physical Resistance/Sticking 339 339
Mechanical Jam 289 289
Leak/Splash 288 288
Expulsion 260 264
Difficult or Delayed Activation 254 254
Material Separation 179 179
Material Deformation 144 144
Retraction Problem 101 101
Material Split, Cut or Torn 84 84
Premature Activation 82 82
Activation Failure 82 82
Product Quality Problem 71 71
Unstable 63 63
Deformation Due to Compressive Stress 54 54
Noise, Audible 52 52
Difficult to Insert 40 40
Material Protrusion/Extrusion 33 33
Difficult to Advance 28 28
Stretched 27 27
Crack 26 26
Material Frayed 23 23
No Apparent Adverse Event 23 23
Difficult to Flush 20 20
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
Patient Device Interaction Problem 10 10
Failure to Advance 10 10
Loose or Intermittent Connection 9 9
Mechanical Problem 8 8
Insufficient Information 8 8
Device Contamination with Chemical or Other Material 8 8
Air/Gas in Device 6 6
Device Dislodged or Dislocated 5 5
Separation Failure 5 5
Defective Device 4 4
Component Missing 4 4
Malposition of Device 3 3
Device Markings/Labelling Problem 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Component Misassembled 3 3
Appropriate Term/Code Not Available 2 2
Activation Problem 2 2
Separation Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Migration or Expulsion of Device 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
Patient-Device Incompatibility 1 1
Failure to Align 1 1
System fails to activate 1 1
Misassembly by Users 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Difficult or Delayed Separation 1 1
Device-Device Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
Positioning Problem 1 1
Scratched Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3644 4208
No Consequences Or Impact To Patient 1954 1954
Mitral Valve Insufficiency/ Regurgitation 1804 2707
Unspecified Tissue Injury 1386 1417
Mitral Regurgitation 1353 1353
Tissue Damage 896 896
Dyspnea 463 463
Foreign Body In Patient 434 438
Mitral Valve Stenosis 393 393
Death 363 363
Heart Failure/Congestive Heart Failure 346 1054
Heart Failure 325 325
No Patient Involvement 272 272
Stroke/CVA 253 268
Pericardial Effusion 237 237
Hemorrhage/Bleeding 220 402
Low Blood Pressure/ Hypotension 219 219
Insufficient Information 208 2047
Renal Failure 141 180
Tricuspid Valve Insufficiency/ Regurgitation 135 135
Embolism/Embolus 124 124
Air Embolism 107 107
Cardiac Arrest 107 165
Atrial Fibrillation 106 169
Myocardial Infarction 105 135
Endocarditis 104 113
Embolism 101 101
Thrombosis/Thrombus 94 94
Cardiogenic Shock 90 90
Thrombosis 87 87
Cardiac Tamponade 86 86
Tricuspid Regurgitation 85 85
Fatigue 68 68
Sepsis 67 67
Arrhythmia 66 66
Perforation 65 65
High Blood Pressure/ Hypertension 57 57
Tachycardia 56 56
Pulmonary Edema 55 55
Respiratory Failure 51 51
Atrial Perforation 42 42
Fever 42 42
Unspecified Infection 41 57
Transient Ischemic Attack 35 42
Shock 33 33
Angina 33 33
Non specific EKG/ECG Changes 31 31
Swelling/ Edema 28 28
Bradycardia 25 25
Hypoxia 25 25
Edema 23 23
Hematoma 20 36
Ventricular Fibrillation 19 19
Rupture 17 17
No Code Available 17 17
Failure of Implant 17 17
Ischemia 17 17
Pain 16 16
Hemolysis 16 16
Anemia 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Intracranial Hemorrhage 13 15
Pleural Effusion 12 12
Cusp Tear 12 12
Respiratory Distress 11 11
Nausea 10 10
Cardiac Enzyme Elevation 10 10
Weakness 10 10
Perforation of Vessels 10 20
Ventricular Tachycardia 9 9
Neurological Deficit/Dysfunction 9 9
Tricuspid Valve Stenosis 9 9
Pulmonary Embolism 8 8
Multiple Organ Failure 8 8
Nervous System Injury 8 11
Syncope/Fainting 7 7
Inflammation 7 7
Hypersensitivity/Allergic reaction 6 6
Vascular Dissection 6 6
No Known Impact Or Consequence To Patient 5 5
Test Result 5 5
Pseudoaneurysm 5 5
Diminished Pulse Pressure 5 5
Foreign Body Embolism 5 5
No Information 5 5
Renal Impairment 5 5
Atrial Flutter 5 5
Fistula 5 5
Anaphylactic Shock 4 4
Seizures 4 4
Cardiac Perforation 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
Intimal Dissection 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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