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)
2021	2022	2023	2024	2025	2026
5	12	20	15	16	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incomplete Coaptation	3253	3287
Adverse Event Without Identified Device or Use Problem	2387	6850
Unintended Movement	2376	2378
Difficult to Open or Close	2006	2006
Difficult or Delayed Positioning	936	937
Insufficient Information	920	922
Positioning Failure	756	757
Difficult to Remove	739	739
Entrapment of Device	601	601
Migration	565	565
Device Damaged by Another Device	448	448
Improper or Incorrect Procedure or Method	414	414
Off-Label Use	406	495
Activation Failure	345	345
Break	313	313
Physical Resistance/Sticking	272	272
Leak/Splash	254	254
Mechanical Jam	234	234
Difficult or Delayed Activation	232	232
Expulsion	214	218
Difficult to Flush	152	152
Material Deformation	149	149
Difficult to Insert	109	109
Patient Device Interaction Problem	108	108
Material Separation	104	104
Air/Gas in Device	88	88
Premature Activation	80	80
Material Split, Cut or Torn	78	79
Retraction Problem	65	65
Deformation Due to Compressive Stress	62	62
Product Quality Problem	56	56
Noise, Audible	41	41
Unstable	41	41
No Apparent Adverse Event	36	36
Malposition of Device	27	27
Crack	26	26
Difficult to Advance	24	24
Material Protrusion/Extrusion	21	21
Material Frayed	21	21
Failure to Advance	15	15
Device Difficult to Setup or Prepare	12	12
Separation Failure	12	13
Tear, Rip or Hole in Device Packaging	11	11
Activation Problem	9	9
Stretched	8	8
Detachment of Device or Device Component	8	8
Device-Device Incompatibility	7	7
Activation, Positioning or Separation Problem	6	6
Loose or Intermittent Connection	6	6
Defective Device	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6696	7265
Mitral Valve Insufficiency/ Regurgitation	3218	4122
Unspecified Tissue Injury	2476	2507
Heart Failure/Congestive Heart Failure	616	1340
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	603	603
Dyspnea	526	526
Foreign Body In Patient	357	361
Tricuspid Valve Insufficiency/ Regurgitation	338	382
Stroke/CVA	310	325
Mitral Valve Stenosis	277	277
Pericardial Effusion	230	231
Insufficient Information	228	2067
Low Blood Pressure/ Hypotension	210	210
Hemorrhage/Bleeding	196	385
Embolism/Embolus	188	188
Air Embolism	173	173
Thrombosis/Thrombus	145	146
Renal Failure	113	154
Cardiac Arrest	101	166
Myocardial Infarction	101	132
Heart Block	88	88
Cardiac Tamponade	84	84
Fatigue	84	84
Atrial Fibrillation	80	153
Perforation	80	80
Endocarditis	79	88
Cardiogenic Shock	74	74
Arrhythmia	72	72
Cardiac Perforation	69	69
Tachycardia	68	68
Cusp Tear	67	67
Unspecified Vascular Problem	62	62
Mitral Regurgitation	57	57
No Consequences Or Impact To Patient	55	55
High Blood Pressure/ Hypertension	54	54
Pulmonary Edema	48	48
Swelling/ Edema	47	47
Unspecified Infection	44	60
Tissue Damage	43	43
Ischemia Stroke	42	42
Transient Ischemic Attack	39	46
Sepsis	38	38
Hypoxia	35	35
Respiratory Failure	33	33
Non specific EKG/ECG Changes	32	32
Angina	31	31
Shock	27	27
Rupture	27	27
Foreign Body Embolism	27	27
Death	27	27