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	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incomplete Coaptation	5506	5540
Adverse Event Without Identified Device or Use Problem	4353	8816
Unintended Movement	2931	2933
Difficult to Open or Close	2748	2748
Difficult to Remove	1389	1389
Difficult or Delayed Positioning	1386	1387
Positioning Failure	984	985
Improper or Incorrect Procedure or Method	955	955
Entrapment of Device	789	789
Migration	777	777
Device Damaged by Another Device	767	767
Off-Label Use	740	829
Break	639	639
Mechanical Jam	557	557
Leak/Splash	481	481
Physical Resistance/Sticking	453	453
Difficult or Delayed Activation	356	356
Failure To Adhere Or Bond	346	346
Expulsion	345	349
Activation Failure	319	319
Difficult To Position	283	283
Material Separation	221	221
Material Deformation	200	200
Difficult to Flush	169	169
Retraction Problem	136	136
Difficult to Insert	125	125
Material Split, Cut or Torn	124	125
Premature Activation	123	123
Detachment Of Device Component	117	117
Mechanical Problem	105	105
Device Operates Differently Than Expected	101	101
Physical Resistance	100	100
Product Quality Problem	98	98
Deformation Due to Compressive Stress	95	95
Patient Device Interaction Problem	90	90
Unstable	89	89
Bent	87	87
Air/Gas in Device	72	72
Noise, Audible	72	72
Material Protrusion/Extrusion	54	54
Stretched	47	47
Crack	44	44
Difficult to Advance	43	43
No Apparent Adverse Event	38	38
Knotted	36	36
Material Frayed	27	27
Failure to Advance	26	26
Physical Property Issue	24	24
Torn Material	23	23
Malposition of Device	23	23

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6321	6890
No Consequences Or Impact To Patient	3576	3576
Mitral Valve Insufficiency/ Regurgitation	3062	3966
Unspecified Tissue Injury	2362	2393
Mitral Regurgitation	2312	2312
Tissue Damage	1497	1497
Dyspnea	878	878
Foreign Body In Patient	672	676
Mitral Valve Stenosis	594	594
Heart Failure/Congestive Heart Failure	590	1314
Death	510	510
No Patient Involvement	493	493
Heart Failure	436	437
Low Blood Pressure/ Hypotension	377	377
Stroke/CVA	372	387
Pericardial Effusion	349	350
Tricuspid Valve Insufficiency/ Regurgitation	317	361
Hemorrhage/Bleeding	306	495
Air Embolism	228	228
Insufficient Information	223	2062
Renal Failure	205	246
Embolism/Embolus	179	179
Cardiac Arrest	170	235
Myocardial Infarction	157	188
Embolism	153	153
Atrial Fibrillation	152	225
Cardiogenic Shock	140	140
Endocarditis	139	148
Thrombosis/Thrombus	139	140
Cardiac Tamponade	139	139
Thrombosis	132	132
Fatigue	126	126
Tricuspid Regurgitation	121	121
Arrhythmia	114	114
Perforation	103	103
High Blood Pressure/ Hypertension	85	85
Tachycardia	82	82
Sepsis	76	76
Respiratory Failure	74	75
Pulmonary Edema	73	73
Atrial Perforation	71	71
Unspecified Infection	70	86
Cusp Tear	61	61
Fever	57	57
Angina	51	51
Transient Ischemic Attack	48	55
Non specific EKG/ECG Changes	47	47
Swelling/ Edema	46	46
Cardiac Perforation	42	42
Shock	42	42