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	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incomplete Coaptation	5709	5743
Adverse Event Without Identified Device or Use Problem	4479	8942
Unintended Movement	3143	3145
Difficult to Open or Close	2908	2908
Difficult or Delayed Positioning	1438	1439
Difficult to Remove	1431	1431
Insufficient Information	1124	1126
Positioning Failure	1047	1048
Improper or Incorrect Procedure or Method	974	974
Entrapment of Device	819	819
Migration	815	815
Device Damaged by Another Device	796	796
Off-Label Use	759	848
Break	661	661
Mechanical Jam	571	571
Leak/Splash	500	500
Physical Resistance/Sticking	476	476
Activation Failure	381	381
Difficult or Delayed Activation	371	371
Expulsion	356	360
Failure To Adhere Or Bond	346	346
Difficult To Position	283	283
Material Separation	224	224
Material Deformation	206	206
Difficult to Flush	176	176
Difficult to Insert	146	146
Retraction Problem	143	143
Premature Activation	133	133
Material Split, Cut or Torn	130	131
Detachment Of Device Component	117	117
Patient Device Interaction Problem	108	108
Mechanical Problem	105	105
Deformation Due to Compressive Stress	102	102
Device Operates Differently Than Expected	101	101
Physical Resistance	100	100
Product Quality Problem	98	98
Air/Gas in Device	93	93
Unstable	92	92
Bent	87	87
Noise, Audible	77	77
Material Protrusion/Extrusion	56	56
Stretched	47	47
No Apparent Adverse Event	46	46
Crack	44	44
Difficult to Advance	44	44
Knotted	36	36
Material Frayed	27	27
Malposition of Device	27	27
Failure to Advance	26	26
Physical Property Issue	24	24

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6820	7389
No Consequences Or Impact To Patient	3576	3576
Mitral Valve Insufficiency/ Regurgitation	3323	4227
Unspecified Tissue Injury	2517	2548
Mitral Regurgitation	2312	2312
Tissue Damage	1497	1497
Dyspnea	909	909
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	700	700
Foreign Body In Patient	692	696
Heart Failure/Congestive Heart Failure	624	1348
Mitral Valve Stenosis	606	606
Death	510	510
No Patient Involvement	493	493
Stroke/CVA	470	485
Heart Failure	436	437
Low Blood Pressure/ Hypotension	382	382
Tricuspid Valve Insufficiency/ Regurgitation	356	400
Pericardial Effusion	353	354
Hemorrhage/Bleeding	321	510
Air Embolism	243	243
Insufficient Information	236	2075
Renal Failure	208	249
Embolism/Embolus	193	193
Cardiac Arrest	184	249
Myocardial Infarction	166	197
Atrial Fibrillation	156	229
Embolism	153	153
Endocarditis	145	154
Thrombosis/Thrombus	145	146
Cardiogenic Shock	140	140
Cardiac Tamponade	138	138
Arrhythmia	135	135
Thrombosis	132	132
Fatigue	131	131
Tricuspid Regurgitation	121	121
Perforation	108	108
Heart Block	92	92
High Blood Pressure/ Hypertension	90	90
Tachycardia	85	85
Sepsis	77	77
Pulmonary Edema	76	76
Cardiac Perforation	75	75
Respiratory Failure	74	75
Unspecified Infection	72	88
Atrial Perforation	71	71
Unspecified Vascular Problem	69	69
Cusp Tear	67	67
Transient Ischemic Attack	63	70
Fever	60	60
Angina	55	55