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 Code	NKM
Device Class	3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
9	1	5	12	20	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incomplete Coaptation	3587	3618
Adverse Event Without Identified Device or Use Problem	3164	7626
Unintended Movement	2239	2239
Difficult to Open or Close	1893	1893
Difficult or Delayed Positioning	952	952
Difficult to Remove	823	823
Positioning Failure	741	741
Off-Label Use	570	570
Entrapment of Device	542	542
Migration	541	541
Improper or Incorrect Procedure or Method	530	530
Device Damaged by Another Device	498	498
Break	399	399
Physical Resistance/Sticking	361	361
Leak/Splash	313	313
Mechanical Jam	307	307
Difficult or Delayed Activation	278	278
Expulsion	278	282
Material Separation	187	187
Material Deformation	156	156
Activation Failure	145	145
Retraction Problem	108	108
Premature Activation	91	91
Material Split, Cut or Torn	91	91
Product Quality Problem	81	81
Difficult to Insert	64	64
Unstable	64	64
Deformation Due to Compressive Stress	63	63
Noise, Audible	61	61
Patient Device Interaction Problem	36	36
Material Protrusion/Extrusion	35	35
Difficult to Advance	34	34
Crack	31	31
Stretched	28	28
No Apparent Adverse Event	27	27
Material Frayed	25	25
Difficult to Flush	20	20
Air/Gas in Device	18	18
Failure to Advance	16	16
Activation, Positioning or Separation Problem	12	12
Device Difficult to Setup or Prepare	12	12
Tear, Rip or Hole in Device Packaging	11	11
Detachment of Device or Device Component	10	10
Loose or Intermittent Connection	9	9
Insufficient Information	9	9
Separation Failure	8	8
Mechanical Problem	8	8
Device Contamination with Chemical or Other Material	8	8
Malposition of Device	7	7
Component Missing	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4384	4948
Mitral Valve Insufficiency/ Regurgitation	2209	3112
No Consequences Or Impact To Patient	1954	1954
Unspecified Tissue Injury	1692	1723
Mitral Regurgitation	1353	1353
Tissue Damage	896	896
Dyspnea	525	525
Foreign Body In Patient	472	476
Mitral Valve Stenosis	426	426
Heart Failure/Congestive Heart Failure	423	1131
Death	363	363
Heart Failure	325	325
Stroke/CVA	275	290
No Patient Involvement	272	272
Pericardial Effusion	263	263
Low Blood Pressure/ Hypotension	249	249
Hemorrhage/Bleeding	240	422
Insufficient Information	208	2047
Tricuspid Valve Insufficiency/ Regurgitation	192	192
Renal Failure	153	192
Embolism/Embolus	143	143
Air Embolism	120	120
Atrial Fibrillation	116	179
Cardiac Arrest	113	171
Myocardial Infarction	112	142
Endocarditis	112	121
Thrombosis/Thrombus	110	110
Embolism	101	101
Cardiac Tamponade	97	97
Cardiogenic Shock	94	94
Thrombosis	87	87
Tricuspid Regurgitation	85	85
Fatigue	80	80
Arrhythmia	77	77
Perforation	73	73
Sepsis	69	69
Tachycardia	67	67
High Blood Pressure/ Hypertension	65	65
Pulmonary Edema	57	57
Respiratory Failure	53	53
Unspecified Infection	46	62
Fever	45	45
Atrial Perforation	42	42
Transient Ischemic Attack	38	45
Angina	37	37
Swelling/ Edema	36	36
Shock	36	36
Non specific EKG/ECG Changes	33	33
Bradycardia	29	29
Hypoxia	29	29