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)
2020	2021	2022	2023	2024	2025
1	5	12	20	15	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incomplete Coaptation	3299	3330
Adverse Event Without Identified Device or Use Problem	2881	7343
Unintended Movement	2174	2174
Difficult to Open or Close	1856	1856
Difficult or Delayed Positioning	914	914
Difficult to Remove	770	770
Positioning Failure	732	732
Migration	542	542
Entrapment of Device	539	539
Off-Label Use	455	455
Device Damaged by Another Device	448	448
Improper or Incorrect Procedure or Method	443	443
Break	320	320
Physical Resistance/Sticking	297	297
Leak/Splash	284	284
Mechanical Jam	249	249
Difficult or Delayed Activation	244	244
Expulsion	231	235
Activation Failure	208	208
Material Deformation	152	152
Material Separation	143	143
Material Split, Cut or Torn	79	79
Premature Activation	76	76
Product Quality Problem	76	76
Retraction Problem	75	75
Difficult to Insert	72	72
Deformation Due to Compressive Stress	57	57
Patient Device Interaction Problem	52	52
Unstable	49	49
Noise, Audible	47	47
Air/Gas in Device	42	42
Material Protrusion/Extrusion	32	32
No Apparent Adverse Event	29	29
Difficult to Advance	27	27
Crack	25	25
Material Frayed	21	21
Stretched	20	20
Failure to Advance	16	16
Difficult to Flush	13	13
Device Difficult to Setup or Prepare	12	12
Malposition of Device	11	11
Tear, Rip or Hole in Device Packaging	11	11
Detachment of Device or Device Component	10	10
Separation Failure	9	9
Activation Problem	8	8
Activation, Positioning or Separation Problem	7	7
Loose or Intermittent Connection	7	7
Device Contamination with Chemical or Other Material	6	6
Insufficient Information	5	5
Device-Device Incompatibility	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5145	5709
Mitral Valve Insufficiency/ Regurgitation	2589	3492
Unspecified Tissue Injury	1989	2020
No Consequences Or Impact To Patient	1003	1003
Mitral Regurgitation	778	778
Tissue Damage	503	503
Dyspnea	502	502
Heart Failure/Congestive Heart Failure	501	1209
Foreign Body In Patient	404	408
Mitral Valve Stenosis	334	334
Stroke/CVA	264	279
Death	260	260
Pericardial Effusion	244	244
Tricuspid Valve Insufficiency/ Regurgitation	235	235
Hemorrhage/Bleeding	229	411
Low Blood Pressure/ Hypotension	220	220
Insufficient Information	211	2050
Heart Failure	210	210
Embolism/Embolus	155	155
No Patient Involvement	142	142
Renal Failure	139	178
Air Embolism	136	136
Thrombosis/Thrombus	124	124
Myocardial Infarction	112	142
Atrial Fibrillation	106	169
Cardiac Arrest	105	163
Endocarditis	97	106
Cardiogenic Shock	93	93
Cardiac Tamponade	93	93
Perforation	81	81
Fatigue	80	80
Tachycardia	68	68
Arrhythmia	66	66
High Blood Pressure/ Hypertension	58	58
Embolism	53	53
Sepsis	52	52
Pulmonary Edema	52	52
Tricuspid Regurgitation	51	51
Unspecified Infection	47	63
Respiratory Failure	45	45
Thrombosis	44	44
Swelling/ Edema	41	41
Cusp Tear	41	41
Fever	35	35
Non specific EKG/ECG Changes	33	33
Transient Ischemic Attack	33	40
Hypoxia	32	32
Angina	32	32
Shock	28	28
Rupture	24	24