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)
2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024	2025
0	0	0	1	8	5	6	4	3	9	1	5	12	20	15	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incomplete Coaptation	5311	5342
Adverse Event Without Identified Device or Use Problem	4175	8637
Unintended Movement	2657	2657
Difficult to Open or Close	2520	2520
Difficult to Remove	1390	1390
Difficult or Delayed Positioning	1305	1305
Improper or Incorrect Procedure or Method	942	942
Positioning Failure	907	907
Entrapment of Device	727	727
Device Damaged by Another Device	715	715
Migration	706	706
Off-Label Use	683	683
Break	631	631
Mechanical Jam	580	580
Leak/Splash	464	464
Failure To Adhere Or Bond	445	445
Physical Resistance/Sticking	426	426
Difficult To Position	358	358
Difficult or Delayed Activation	330	330
Expulsion	323	327
Activation Failure	238	238
Material Separation	216	216
Material Deformation	186	186
Detachment Of Device Component	154	154
Bent	129	129
Retraction Problem	128	128
Mechanical Problem	120	120
Physical Resistance	116	116
Device Operates Differently Than Expected	116	116
Premature Activation	114	114
Material Split, Cut or Torn	111	111
Difficult to Insert	109	109
Product Quality Problem	97	97
Unstable	90	90
Deformation Due to Compressive Stress	82	82
Noise, Audible	67	67
Patient Device Interaction Problem	59	59
Material Protrusion/Extrusion	55	55
Stretched	49	49
Air/Gas in Device	47	47
Knotted	43	43
Crack	42	42
Difficult to Advance	41	41
No Apparent Adverse Event	34	34
Difficult to Flush	32	32
Torn Material	28	28
Physical Property Issue	27	27
Material Frayed	27	27
Failure to Advance	26	26
Insufficient Information	18	18

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5352	5916
No Consequences Or Impact To Patient	3797	3797
Mitral Valve Insufficiency/ Regurgitation	2691	3594
Mitral Regurgitation	2460	2460
Unspecified Tissue Injury	2064	2095
Tissue Damage	1578	1578
Dyspnea	836	836
Foreign Body In Patient	666	670
Mitral Valve Stenosis	571	571
Death	556	556
No Patient Involvement	521	521
Heart Failure/Congestive Heart Failure	515	1223
Heart Failure	452	453
Low Blood Pressure/ Hypotension	371	371
Stroke/CVA	346	361
Pericardial Effusion	332	332
Hemorrhage/Bleeding	290	472
Tricuspid Valve Insufficiency/ Regurgitation	252	252
Insufficient Information	216	2055
Renal Failure	193	232
Air Embolism	190	190
Cardiac Arrest	172	230
Embolism	161	161
Embolism/Embolus	159	159
Atrial Fibrillation	147	210
Myocardial Infarction	145	175
Cardiogenic Shock	142	142
Thrombosis	140	140
Endocarditis	134	143
Cardiac Tamponade	130	130
Thrombosis/Thrombus	125	125
Tricuspid Regurgitation	121	121
Fatigue	120	120
Arrhythmia	104	105
Perforation	93	93
High Blood Pressure/ Hypertension	86	86
Atrial Perforation	81	81
Respiratory Failure	80	81
Sepsis	78	78
Tachycardia	75	75
Pulmonary Edema	72	72
Unspecified Infection	72	88
Fever	56	56
Angina	51	51
Cusp Tear	45	45
Non specific EKG/ECG Changes	43	43
Transient Ischemic Attack	43	50
Swelling/ Edema	42	42
Edema	42	42
Shock	41	41