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)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
0	0	0	0	1	8	5	6	4	3	9	1	5	12	20	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incomplete Coaptation	4989	5020
Adverse Event Without Identified Device or Use Problem	3965	8427
Unintended Movement	2363	2363
Difficult to Open or Close	2218	2218
Difficult to Remove	1409	1409
Difficult or Delayed Positioning	1183	1183
Improper or Incorrect Procedure or Method	897	897
Positioning Failure	792	792
Entrapment of Device	672	672
Device Damaged by Another Device	667	667
Off-Label Use	643	643
Migration	599	599
Break	591	591
Mechanical Jam	586	586
Failure To Adhere Or Bond	516	516
Leak/Splash	453	453
Difficult To Position	420	420
Physical Resistance/Sticking	387	387
Difficult or Delayed Activation	310	310
Expulsion	305	309
Material Separation	203	203
Detachment Of Device Component	181	181
Material Deformation	172	172
Bent	147	147
Activation Failure	146	146
Device Operates Differently Than Expected	127	127
Mechanical Problem	123	123
Retraction Problem	123	123
Physical Resistance	122	122
Premature Activation	106	106
Material Split, Cut or Torn	99	99
Difficult to Insert	91	91
Product Quality Problem	89	89
Unstable	87	87
Deformation Due to Compressive Stress	77	77
Noise, Audible	65	65
Material Protrusion/Extrusion	53	53
Knotted	51	51
Stretched	49	49
Crack	41	41
Difficult to Advance	38	38
Patient Device Interaction Problem	36	36
Torn Material	34	34
Difficult to Flush	31	31
No Apparent Adverse Event	28	28
Physical Property Issue	27	27
Material Frayed	25	25
Failure to Advance	25	25
Insufficient Information	19	19
Air/Gas in Device	18	18

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4384	4948
No Consequences Or Impact To Patient	3991	3991
Mitral Regurgitation	2609	2609
Mitral Valve Insufficiency/ Regurgitation	2209	3112
Unspecified Tissue Injury	1692	1723
Tissue Damage	1657	1657
Dyspnea	773	773
Foreign Body In Patient	641	645
Death	596	596
Mitral Valve Stenosis	535	535
No Patient Involvement	526	526
Heart Failure	480	481
Heart Failure/Congestive Heart Failure	423	1131
Low Blood Pressure/ Hypotension	362	362
Stroke/CVA	326	341
Pericardial Effusion	305	305
Hemorrhage/Bleeding	275	457
Insufficient Information	208	2047
Tricuspid Valve Insufficiency/ Regurgitation	192	192
Renal Failure	186	225
Embolism	169	169
Cardiac Arrest	166	224
Air Embolism	159	159
Thrombosis	154	154
Atrial Fibrillation	151	214
Embolism/Embolus	143	143
Endocarditis	134	143
Myocardial Infarction	131	161
Cardiogenic Shock	130	130
Tricuspid Regurgitation	121	121
Cardiac Tamponade	118	118
Thrombosis/Thrombus	110	110
Fatigue	108	108
Arrhythmia	99	100
Atrial Perforation	90	90
High Blood Pressure/ Hypertension	86	86
Perforation	84	84
Sepsis	79	79
Respiratory Failure	79	80
Pulmonary Edema	73	73
Tachycardia	69	69
Unspecified Infection	68	84
Fever	60	60
No Code Available	51	51
Angina	48	48
Edema	47	47
Transient Ischemic Attack	42	49
Non specific EKG/ECG Changes	41	41
Shock	40	40
Swelling/ Edema	36	36