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	16

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incomplete Coaptation	5604	5638
Adverse Event Without Identified Device or Use Problem	4399	8862
Unintended Movement	2867	2869
Difficult to Open or Close	2740	2740
Difficult to Remove	1443	1443
Difficult or Delayed Positioning	1378	1379
Improper or Incorrect Procedure or Method	974	974
Positioning Failure	971	972
Entrapment of Device	784	784
Device Damaged by Another Device	770	770
Migration	762	762
Off-Label Use	740	829
Break	661	661
Mechanical Jam	596	596
Leak/Splash	488	488
Physical Resistance/Sticking	445	445
Failure To Adhere Or Bond	444	444
Difficult To Position	358	358
Difficult or Delayed Activation	355	355
Expulsion	343	347
Activation Failure	307	307
Material Separation	220	220
Material Deformation	199	199
Difficult to Flush	168	168
Detachment Of Device Component	154	154
Retraction Problem	136	136
Bent	129	129
Difficult to Insert	128	128
Premature Activation	122	122
Material Split, Cut or Torn	122	123
Mechanical Problem	120	120
Device Operates Differently Than Expected	116	116
Physical Resistance	116	116
Product Quality Problem	98	98
Deformation Due to Compressive Stress	93	93
Unstable	91	91
Patient Device Interaction Problem	84	84
Noise, Audible	71	71
Air/Gas in Device	68	68
Material Protrusion/Extrusion	56	56
Stretched	49	49
Crack	45	45
Difficult to Advance	43	43
Knotted	43	43
No Apparent Adverse Event	38	38
Torn Material	28	28
Failure to Advance	27	27
Physical Property Issue	27	27
Material Frayed	27	27
Malposition of Device	21	21

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6156	6725
No Consequences Or Impact To Patient	3797	3797
Mitral Valve Insufficiency/ Regurgitation	3004	3908
Mitral Regurgitation	2460	2460
Unspecified Tissue Injury	2310	2341
Tissue Damage	1578	1578
Dyspnea	894	894
Foreign Body In Patient	686	690
Mitral Valve Stenosis	594	594
Heart Failure/Congestive Heart Failure	570	1294
Death	556	556
No Patient Involvement	521	521
Heart Failure	452	453
Low Blood Pressure/ Hypotension	387	387
Stroke/CVA	371	386
Pericardial Effusion	348	349
Tricuspid Valve Insufficiency/ Regurgitation	310	354
Hemorrhage/Bleeding	309	498
Air Embolism	225	225
Insufficient Information	219	2058
Renal Failure	206	247
Cardiac Arrest	181	246
Embolism/Embolus	177	177
Embolism	161	161
Myocardial Infarction	157	188
Atrial Fibrillation	154	227
Cardiogenic Shock	146	146
Cardiac Tamponade	141	141
Thrombosis	140	140
Endocarditis	138	147
Thrombosis/Thrombus	133	134
Fatigue	128	128
Tricuspid Regurgitation	121	121
Arrhythmia	114	115
Perforation	102	102
High Blood Pressure/ Hypertension	89	89
Atrial Perforation	81	81
Tachycardia	81	81
Respiratory Failure	80	81
Sepsis	79	79
Unspecified Infection	75	91
Pulmonary Edema	75	75
Cusp Tear	58	58
Fever	58	58
Angina	52	52
Non specific EKG/ECG Changes	46	46
Swelling/ Edema	46	46
Transient Ischemic Attack	46	53
Edema	42	42
Shock	41	41