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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)
2017 2018 2019 2020 2021 2022
4 3 9 1 5 4

MDR Year MDR Reports MDR Events
2017 1138 1138
2018 1668 1668
2019 2278 2278
2020 2724 2724
2021 2346 5587
2022 1554 2723

Device Problems MDRs with this Device Problem Events in those MDRs
Incomplete Coaptation 3200 3231
Adverse Event Without Identified Device or Use Problem 2708 7083
Unintended Movement 1402 1402
Difficult to Open or Close 1374 1374
Difficult to Remove 833 833
Difficult or Delayed Positioning 712 712
Improper or Incorrect Procedure or Method 625 625
Positioning Failure 496 496
Off-Label Use 467 467
Device Damaged by Another Device 444 444
Break 385 385
Mechanical Jam 382 382
Migration 375 375
Entrapment of Device 363 363
Leak/Splash 325 325
Physical Resistance/Sticking 300 300
Failure To Adhere Or Bond 239 239
Expulsion 211 215
Difficult or Delayed Activation 208 208
Material Separation 179 179
Difficult To Position 169 169
Material Deformation 96 96
Retraction Problem 95 95
Mechanical Problem 89 89
Material Split, Cut or Torn 76 76
Detachment Of Device Component 73 73
Unstable 68 68
Premature Activation 65 65
Product Quality Problem 64 64
Physical Resistance 63 63
Device Operates Differently Than Expected 62 62
Deformation Due to Compressive Stress 55 55
Bent 50 50
Noise, Audible 45 45
Material Protrusion/Extrusion 42 42
Stretched 41 41
Difficult to Insert 37 37
Difficult to Flush 29 29
Crack 29 29
Difficult to Advance 28 28
Torn Material 21 21
Knotted 20 20
Activation Failure 19 19
Physical Property Issue 18 18
Failure to Advance 13 13
Activation, Positioning or SeparationProblem 12 12
Device Contamination with Chemical or Other Material 12 12
Material Frayed 12 12
Insufficient Information 12 12
No Apparent Adverse Event 11 11
Tear, Rip or Hole in Device Packaging 10 10
Loose or Intermittent Connection 7 7
Kinked 6 6
Out-Of-Box Failure 5 5
Device Dislodged or Dislocated 4 4
Component Missing 4 4
Device Expiration Issue 3 3
Defective Device 3 3
Detachment of Device or Device Component 3 3
Device Markings/Labelling Problem 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Component Misassembled 3 3
Inaccurate Information 2 2
Failure to Align 2 2
Material Twisted/Bent 2 2
Therapeutic or Diagnostic Output Failure 2 2
Misconnection 2 2
Unsealed Device Packaging 1 1
Peeled/Delaminated 1 1
Migration or Expulsion of Device 1 1
Device Difficult to Setup or Prepare 1 1
System fails to activate 1 1
Device Inoperable 1 1
Fluid Leak 1 1
Loss of or Failure to Bond 1 1
Flushing Problem 1 1
Positioning Problem 1 1
Scratched Material 1 1
Separation Failure 1 1
Failure to Form Staple 1 1
Activation Problem 1 1
Firing Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3188 3188
Mitral Regurgitation 2068 2068
No Clinical Signs, Symptoms or Conditions 1787 2317
Tissue Damage 1376 1376
Mitral Valve Insufficiency/ Regurgitation 871 1748
Unspecified Tissue Injury 694 725
Dyspnea 481 481
Death 458 458
No Patient Involvement 455 455
Foreign Body In Patient 443 447
Heart Failure 412 412
Mitral Valve Stenosis 392 392
Stroke/CVA 221 236
Low Blood Pressure/ Hypotension 220 220
Pericardial Effusion 208 208
Heart Failure/Congestive Heart Failure 173 861
Insufficient Information 172 2004
Hemorrhage/Bleeding 172 354
Embolism 145 145
Thrombosis 126 126
Renal Failure 122 161
Tricuspid Regurgitation 120 120
Atrial Fibrillation 101 164
Cardiac Arrest 100 158
Endocarditis 93 102
Cardiogenic Shock 91 91
Air Embolism 89 89
Myocardial Infarction 80 110
Cardiac Tamponade 77 77
Atrial Perforation 67 67
Fatigue 66 66
Sepsis 60 60
Embolism/Embolus 55 55
Respiratory Failure 53 53
Arrhythmia 53 53
Perforation 49 49
Tricuspid Valve Insufficiency/ Regurgitation 49 49
High Blood Pressure/ Hypertension 48 48
Thrombosis/Thrombus 45 45
Pulmonary Edema 44 44
Tachycardia 39 39
Unspecified Infection 39 55
Fever 39 39
Edema 36 36
Angina 29 29
Transient Ischemic Attack 29 36
Non specific EKG/ECG Changes 26 26
Shock 24 24
No Code Available 21 21
Bradycardia 20 20
Anemia 19 19
Hemolysis 18 18
Respiratory Distress 17 17
Hematoma 17 33
Ventricular Fibrillation 17 17
Swelling/ Edema 14 14
Ischemia 13 13
Neurological Deficit/Dysfunction 13 13
Weakness 12 12
No Known Impact Or Consequence To Patient 12 12
Ventricular Tachycardia 11 11
Cardiac Enzyme Elevation 11 11
Intracranial Hemorrhage 10 12
Failure of Implant 10 10
Nausea 9 9
Hypoxia 9 9
Test Result 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Tricuspid Valve Stenosis 8 8
Inflammation 7 7
Fistula 7 7
No Information 7 7
Nervous System Injury 6 9
Pain 6 6
Pulmonary Embolism 5 5
Atrial Flutter 5 5
Pseudoaneurysm 5 5
Visual Disturbances 5 5
Diminished Pulse Pressure 4 4
Renal Impairment 4 4
Seizures 4 4
Hypersensitivity/Allergic reaction 4 4
Occlusion 3 3
Pleural Effusion 3 3
Atrial Tachycardia 3 3
Syncope 3 3
Aneurysm 3 3
Anaphylactic Shock 3 3
Multiple Organ Failure 3 3
Vascular Dissection 3 3
Perforation of Vessels 3 13
Rupture 3 3
Dizziness 2 2
Tissue Breakdown 2 2
Unspecified Kidney or Urinary Problem 2 2
Convulsion/Seizure 2 2
Syncope/Fainting 2 2
Intimal Dissection 2 2
Calcium Deposits/Calcification 2 2
Pneumonia 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II May-29-2019
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