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)
2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024	2025	2026
0	0	1	8	5	6	4	3	9	1	5	12	20	15	16	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incomplete Coaptation	4991	5025
Adverse Event Without Identified Device or Use Problem	4166	8629
Unintended Movement	3265	3267
Difficult to Open or Close	2813	2813
Difficult or Delayed Positioning	1333	1334
Difficult to Remove	1126	1126
Insufficient Device Problem Information	1121	1123
Positioning Failure	1076	1077
Migration	839	839
Entrapment of Device	773	773
Off-Label Use	768	857
Improper or Incorrect Procedure or Method	735	735
Device Damaged by Another Device	705	705
Break	549	549
Physical Resistance/Sticking	494	494
Leak/Splash	411	411
Activation Failure	407	407
Difficult or Delayed Activation	389	389
Mechanical Jam	383	383
Expulsion	362	366
Material Separation	227	227
Material Deformation	208	208
Difficult to Flush	170	170
Difficult to Insert	144	144
Retraction Problem	141	141
Material Split, Cut or Torn	132	133
Premature Activation	130	130
Patient Device Interaction Problem	115	115
Deformation Due to Compressive Stress	107	107
Air/Gas in Device	100	100
Product Quality Problem	99	99
Unstable	83	83
Noise, Audible	77	77
No Apparent Adverse Event	50	50
Material Protrusion/Extrusion	47	47
Difficult to Advance	44	44
Crack	36	36
Malposition of Device	32	32
Stretched	29	29
Material Frayed	27	27
Failure to Advance	21	21
Tear, Rip or Hole in Device Packaging	17	17
Device Difficult to Setup or Prepare	12	12
Separation Failure	11	11
Device Contamination with Chemical or Other Material	11	11
Mechanical Problem	10	10
Loose or Intermittent Connection	9	9
Activation Problem	9	9
Activation, Positioning or Separation Problem	9	9
Device-Device Incompatibility	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7100	7669
No Consequences Or Impact To Patient	3576	3576
Mitral Valve Insufficiency/ Regurgitation	3445	4349
Unspecified Tissue Injury	2613	2644
Mitral Regurgitation	2312	2312
Tissue Damage	1497	1497
Dyspnea	936	936
Foreign Body In Patient	704	708
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	700	700
Heart Failure/Congestive Heart Failure	644	1368
Mitral Valve Stenosis	612	612
Death	510	510
No Patient Involvement	493	493
Stroke/CVA	474	489
Heart Failure	436	437
Low Blood Pressure/ Hypotension	394	394
Tricuspid Valve Insufficiency/ Regurgitation	383	427
Pericardial Effusion	357	358
Hemorrhage/Blood Loss/Bleeding	328	517
Air Embolism	248	248
Insufficient Information	247	2086
Renal Failure	212	253
Embolism/Embolus	199	199
Cardiac Arrest	185	250
Myocardial Infarction	166	197
Atrial Fibrillation	157	230
Embolism	153	153
Thrombosis/Thrombus	150	151
Endocarditis	145	154
Cardiogenic Shock	142	142
Cardiac Tamponade	139	139
Arrhythmia	136	136
Fatigue	134	134
Thrombosis	132	132
Tricuspid Regurgitation	121	121
Perforation	112	112
High Blood Pressure/ Hypertension	94	94
Heart Block	93	93
Tachycardia	87	87
Sepsis	80	80
Cardiac Perforation	79	79
Pulmonary Edema	77	77
Respiratory Failure	75	76
Unspecified Infection	73	89
Atrial Perforation	71	71
Unspecified Vascular Problem	69	69
Cusp Tear	68	68
Transient Ischemic Attack	63	70
Fever	60	60
Angina	55	55